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AKI ICON

acute kidney injury (AKI) following coronary artery bypass graft (CABG) and/or valve surgery

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.
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ACURATE IDE

aortic stenosis

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
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Disrupt CAD III

coronary artery disease

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.
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SUMMIT

Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)

Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-Randomized and MAC cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-randomized cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.
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BIOFLOW VII

coronary artery disease

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).
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REDUCE LAP

heart failure

Following supine bicycle exercise testing to assess eligibility, the eligible patients are randomized to the treatment or control group. All patients will be sedated, and both treatment and control arm patients will undergo placement of a femoral venous access sheath after randomization. Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium. Patients will be evaluated at pre-specified time intervals and followed for 5 years. All patients will be unblinded after the 24 month follow up visit. Patients randomized to the control arm will be allowed to cross-over to the treatment arm at ≥ 24 months post-control procedure provided patient selection criteria are met at that time. Cross-over patients will then be followed for 5 years after cross-over.
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WARRIOR

coronary artery disease

The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no obstructive CAD. The hypothesis is that IMT will reduce major adverse coronary events (MACE) 20% vs. UC. The primary outcome is first occurrence of MACE as death, nonfatal MI, nonfatal stroke/transient ischemic attack (TIA) or hospitalization for heart failure or angina. Secondary outcomes include quality of life, time to "return to duty"/work, health resource consumption, angina, cardiovascular (CV) death and primary outcome components. Events will be adjudicated by an experienced Clinical Events Committee (CEC). Follow-up will be 3-years using 50 sites: primarily VA and Active Duty Military Hospitals/Clinics and a National Patient-Centered Clinical Research Network (PCORnet) clinical data research network (CDRN)(OneFlorida Consortium). This study is being conducted to determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being hospitalized for cardiac reasons. The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients, and ultimately improve the patient's cardiac health and quality of life and reduce health-care costs.
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VENT AVOID

Chronic Obstructive Pulmonary Disease (COPD)

This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation compared to COPD patients treated with standard-of-care mechanical ventilation alone. Eligible patients will be randomized to receive lung support with either the Hemolung RAS plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation alone.
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VHD Screening in New Ulm

heart valve disease

While many people are familiar with heart disease and heart attacks, there’s another serious heart condition that impacts more than 5 million Americans, half of whom are age 65 and older. It’s called valvular heart disease (VHD), and it occurs when the heart valves do not work properly to keep blood flowing through the heart. Left untreated, heart valve disease can cause heart attacks, irregular heart rhythms, congestive heart failure and other heart conditions, significantly impacting a person’s quality of life and potentially leading to an untimely death. To help older adults in New Ulm, Minn., and the surrounding area determine if they might already have heart valve disease and not be aware of it, MHIF, in partnership with The Heart of New Ulm (HONU) and New Ulm Medical Center (NUMC), part of Allina Health, are conducting free heart valve disease screenings for eligible adults age 65 and older. The screenings, funded by the Abbott Northwestern Hospital Foundation, are part of an MHIF research project that is the first prospective population VHD screening study done in the United States.
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R1500

Hypercholesterolemia

The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.
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EXPAND HEART CAP

heart failure/transplant candidate

The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
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A DUE

pulmonary arterial hypertension (PAH)

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective that therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
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TRILUMINATE Pivotal

tricuspid regurgitation

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
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cvMOBIUS

recent atherosclerotic cardiovascular disease (ASCVD) event

cvMOBIUS is a North American registry of patients with ASCVD aimed at understanding patterns of care in ASCVD while evaluating the real world effectiveness of PCSK9 inhibitors.
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GUIDE-HF

heart failure

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
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SURPOINT COA

paroxysmal atrial fibrillation

Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit.
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RADIANCE-HTN

hypertension

RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.
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PROMINENT

Type 2 diabetes

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: nonfatal Myocardial Infarction (MI) nonfatal ischemic stroke hospitalization for unstable angina requiring unplanned coronary revascularization; or Cardiovascular (CV) death.
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HEART-FID

heart failure with iron deficiency anemia

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction.
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ARTESIA

atrial fibrillation

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.
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Portico NG

symptomatic, severe native aortic stenosis

The Portico NG Approval study will be conducted as a prospective, multi-center, international, single-arm investigational study. High or extreme risk patients with symptomatic, severe native aortic stenosis who are determined by an independent subject selection committee to meet eligibility criteria for Portico NG Transcatheter Aortic Heart Valve implantation will undergo Portico™ NG Valve implantation via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR (transcatheter aortic valve replacement) procedure.
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PROGRESS-CTO

coronary artery disease

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.
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ALt FLOW

heart failure

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
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DCD Heart Trial

heart failure/transplant candidate

To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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ANT004

atrial fibrillation

This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of MAA868 in patients with atrial fibrillation (AF) or flutter at low risk of thromboembolic stroke or peripheral embolism.
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CASCADE FH

Familial Hypercholesterolemia (FH)

The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy, clinical outcomes, and patient-reported outcomes over time. The registry represents a collaboration between The Familial Hypercholesterolemia Foundation, the Duke Clinical Research Institute, lipid specialists, cardiologists, primary care providers, quality improvement personnel, and patients, all aiming to increase FH awareness, promote optimal disease management, and improve FH outcomes.
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VESALIUS

coronary heart disease

This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.
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PIONEER III

coronary artery disease

The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents. This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to 1632 subjects at up to 130 investigational sites in North America, Japan, and Europe. Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years.
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SPYRAL ON-MED

hypertension

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.
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REBIRTH

undergoing cardiac catheterization

This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.
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Zenith® p-Branch™

abdominal aortic aneurysms

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
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OPTION

atrial fibrillation

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
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MitraClip Expand G4

mitral valve regurgitation

This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
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EARLY TAVR

asymptomatic, severe aortic stenosis

This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
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PFO Occluder PAS

ischemic stroke

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
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REDUCE PAS

ischemic stroke with presence of Patent Foramen Ovale (PFO)

This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
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PACES

Quitting smoking following acute coronary syndrome

Quitting smoking following acute coronary syndrome (ACS) can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). Objective: For this R01 the investigators will evaluate the efficacy of using a single, integrated treatment that targets both depressed mood and smoking (BAT-CS).
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RHAPSODY

recurrent pericarditis

This is a Phase 3, global, multi-center, double-blind, placebo-controlled, randomized withdrawal study with open-label extension, to assess the efficacy and safety of rilonacept treatment in subjects with recurrent pericarditis.
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RESCUE 3

ventilator-induced diaphragm dysfunction

This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and failed two weaning attempts. The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.
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EXACT

angina

The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).
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AEGIS II

acute coronary syndrome

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.
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LOWER

familial hypercholesterolemia (FH)

This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.
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AccuCinch 5017

heart failure and reduced ejection fraction

Condition: heart failure and reduced ejection fraction
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ECLIPSE

stable ischemic heart disease; unstable angina

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).
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MINT

heart attack

The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.
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QDOT IDE

atrial fibrillation

Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
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GAC Registry

genetic arrhythmia

The primary objective of this registry is to collect data by using the subject’s complete medical history, clinic notes, diagnosis, long-term treatment, and health outcomes generated through the standard clinical care that is provided to the patients at the Genetic Arrhythmia Center on an ongoing basis.
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OPUS Registry

pulmonary arterial hypertension

Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
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EV ICD

tachycardia, ventricular arrhythmia

The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
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RADIANCE II

Stage 2 hypertension

The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.
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DESIFOR

statin-eligible patients

This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects. Research has shown that many people who have muscle symptoms on statin therapy do not experience the same side effects if they try it again later. This study is part of a larger effort to: See how common it is for patients to still be intolerant of statin medication after trying it a second time; and For those patients who do tolerate being on a statin after trying it a second time, see how common it is for them to still be taking the statin 3 months after completing the main part of the study. Patients who agree to participate will be given a 5 month randomly allocated supply of statin and placebo and track their symptoms weekly.
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Lp(A)

cardiovascular disease and Lipoprotein(a)

The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).
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