Research Study: AccuCinch 5019
Condition:
heart failure and reduced ejection fraction
Study Sponsor: Ancora Heart
Study Investigator: Peter Eckman, MD
Study Contact: Jacob Jensen
jacob.jensen@allina.com
612-863-8818
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:

This is a prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
Eligibility Criteria:

  • Age 18-years or older
  • Ejection Fraction: ≥20% and ≤40%
  • LV end-diastolic diameter ≥55 mm
  • Symptom Status:
    • NYHA III,
    • NYHA ambulatory IV, or
    • NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
  • Able to complete six-minute walk test with distance between 100 m and 450 m.
  • Treatment with guideline-directed medical and device-based therapies for heart failure. Medical treatments should have been established for at least 90 days prior to obtaining consent and doses of medications should be stable for at least 30 days prior to baseline screening, with "stable" defined as no more than 100% increase or 50% decrease of total daily doses. When applicable, device-based therapies should include:
    • A CRT device, which is required for at least 90 days prior to baseline screening in subjects with left bundle branch block pattern and QRS duration >/=150 ms
    • An ICD, which is required for all patients in whom it is indicated (based on best local clinical practice) for at least 30 days prior to baseline screening
  • Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

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!