Research Study: GUIDE-HF
Condition:
heart failure
Study Sponsor: Abbott Vascular
Study Investigator: Mosi Bennett, MD
Study Contact: Kari Thomas
kari.m.thomas@allina.com
612-863-7493
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

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.
Eligibility Criteria:

  • Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:

    a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.

  • GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
  • GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
  • HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:
    • Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
    • Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
    • Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
  • ≥ 18 years of age
  • Chest circumference of < 65 inches, if BMI is > 35 kg/m2
  • Written informed consent obtained from subject
  • Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!