AccuCinch® System for Heart Failure
(CorCinch-HFrEF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).
Will I have to stop taking my current medications?
The trial requires that you have been on stable doses of your current heart failure medications for at least one month before joining. This means you should not change your medication doses significantly during this time.
How is the AccuCinch® Ventricular Restoration System treatment different from other heart failure treatments?
The AccuCinch® Ventricular Restoration System is unique because it uses a series of anchors and a cable to reshape the left ventricle of the heart, reducing stress on the heart wall and potentially reversing heart damage. This approach is different from other treatments that may focus on medication or more invasive surgeries, as it is a minimally invasive procedure aimed at physically restoring the heart's shape and function.12345
What data supports the effectiveness of the AccuCinch® Ventricular Restoration System treatment for heart failure?
The AccuCinch® Ventricular Restoration System is similar to other cardiac support devices that aim to improve heart function by reshaping the heart's structure. Research on ventricular assist devices and cardiac support devices shows they can help improve heart shape, size, and function, which suggests potential benefits for the AccuCinch® system in treating heart failure.34678
Who Is on the Research Team?
Azeem Latib, MD
Principal Investigator
Montefiore Medical Center
Michael Zapien, MS, CCRA
Principal Investigator
Ancora Heart, Inc.
Ulrich Jorde, MD
Principal Investigator
Montefiore Medical Center
Are You a Good Fit for This Trial?
Adults with heart failure and reduced ejection fraction (HFrEF), specifically those with a left ventricular diameter ≥55 mm, ejection fraction between 20-40%, and stable on optimal heart failure therapies. Participants must have certain devices like CRT or ICD implanted for specified durations before enrollment, be able to perform diagnostic tests, follow the study schedule, and have NYHA class III-IV symptoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the AccuCinch® Ventricular Restoration System
Follow-up
Participants are monitored for safety and effectiveness after treatment
Safety Monitoring
Safety measured by device-related or procedure-related major adverse events (MAEs)
What Are the Treatments Tested in This Trial?
Interventions
- AccuCinch® Ventricular Restoration System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ancora Heart, Inc.
Lead Sponsor