Enrolling Studies at the Minneapolis Heart Institute Foundation

Article Citation:

(2018) Enrolling Studies at the Minneapolis Heart Institute Foundation. Journal of the Minneapolis Heart Institute Foundation: Spring/Summer 2018, Vol. 2, No. 1, pp. 57-59.


Enrolling Studies at the Minneapolis Heart Institute FoundationMore information can be found at www.mplsheart.org and www.clinicaltrials.gov.

A Phase I, First-in-Human, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Cancer Survivors With Anthracycline-Induced Cardiomyopathy

The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC). The secondary purpose of this study is to obtain preliminary evidence for therapeutic efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV dysfunction secondary to AIC.

A Phase II, Randomized, Placebo-Controlled Study of the Safety, Feasibility, and Efficacy of Autologous Mesenchymal Stem Cells and C-kit+ Cardiac Stem Cells, Alone or in Combination, Administered Transendocardially in Subjects With Ischemic Heart Failure

This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and efficacy of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs), delivered alone or in combination (Combo), administered by transendocardial injection in subjects with ischemic cardiomyopathy.

A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4–12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Attain Stability™ Quad Clinical Study

The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).

Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

CASCADE FH Registry (CAscade SCreening for Awareness and DEtection of Familial Hypercholesterolemia Registry)

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

COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic)

The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

Early Feasibility Study of the AccuCinch® Ventriculoplasty System

Multi-center, prospective single-arm early feasibility study to evaluate AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair. Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.

Expanded Clinical Study of the Tendyne Mitral Valve System

The purpose of this study is to generate initial insights into the safety and performance of the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral regurgitation who are not suitable candidates for conventional mitral valve repair or replacement. The study will include up to 110 subjects at up to 25 centers. Follow-up evaluations will be conducted through 2 years post implantation.

Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) a Registry of High Cardiovascular Risk Subjects in the United States

This is a multicenter observational cohort study with both retrospective and prospective data collection components in subjects with ASCVD. The purpose of this study is to better understand cholesterol treatment patterns in the context of a changing landscape in subjects with ASCVD.

Medtronic Product Surveillance Registry

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

MOMENTUM 3 CAP Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol

The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.


The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.

Real-World Effectiveness Study of PuraPly™ AM on Wounds

The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.

Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI)

Clopidogrel is an anti-platelet medication approved by the U.S. Federal Drug Administration (FDA) for use in patients who undergo percutaneous coronary intervention (PCI) with coronary stent implantation. Anti-platelet medications work to prevent blood clots from forming. Some studies have suggested that patients who have a certain genetic liver enzyme abnormality (known as cytochrome P450 2C19 [CYP2C19] *2 or *3 allele) may have a reduced ability to activate clopidogrel, and therefore may have a lowered response to clopidogrel. It is thought that up to 30% of people who have a coronary stent procedure may have this genetic liver enzyme abnormality. There is a FDA approved genetic test available that determines within 45 minutes whether or not someone has this genetic liver enzyme abnormality. Ticagrelor is a newer anti-platelet drug that is not dependent on the CYP2C19 liver enzyme for its activation and hence in poor clopidogrel metabolizers, alternative drugs like Ticagrelor have been recommended for use as an anti-platelet agent after PCI. The purpose of this study is to determine if genetic testing can identify the best anti-platelet therapy, for patients who undergo coronary stent placement and do not activate clopidogrel very well.

The “RADIANCE-HTN” Study. A Study of the ReCor Medical Paradise System in Clinical 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.

Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)

The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.

Zenith® p-Branch® Pivotal Study

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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