AccuCinch® System for Heart Failure

(CorCinch-HFrEF Trial)

Recruiting at 21 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ancora Heart, Inc.

Must not be taking: High dose steroids

Disqualifiers: Recent MI, Severe valve disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

22 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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

Eligibility Criteria

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

Your heart's ejection fraction is between 20% and 40%.

Your heart's left ventricle is too big, with a diameter of 55 millimeters or more.

I have heart issues but can still walk around.

Exclusion Criteria

I have heart artery disease that hasn't been treated with surgery.

My kidney function is severely reduced.

I have an ongoing heart infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AccuCinch® Ventricular Restoration System

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Safety Monitoring

Safety measured by device-related or procedure-related major adverse events (MAEs)

30 days

Treatment Details

Interventions

• AccuCinch® Ventricular Restoration System

Trial Overview The trial is testing the AccuCinch® Ventricular Restoration System in patients with HFrEF. It's an early-stage study that's not randomized but is prospective and multi-center. The goal is to see how well this system works in improving heart function by cinching the ventricle.

Participant Groups

Group I: AccuCinch® Ventricular Restoration System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ancora Heart, Inc.

Lead Sponsor

Trials

9

Recruited

620+

Findings from Research

Ventricular assist devices, particularly left ventricular assist systems like the HeartMate, are effective in treating severe heart failure and can serve as both short- and long-term solutions for patients awaiting heart transplants.

These devices not only help patients survive until a transplant but also have the potential to improve heart function in some cases, suggesting they may become a more common alternative to transplantation in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development, evolution, and clinical utilization of artificial heart technology. Frazier, OH.[2004]

In a study of 54 patients with post-infarction left-ventricular aneurysms, linear endoventricular patch plasty significantly improved heart function, evidenced by a decrease in end-diastolic volume and an increase in ejection fraction over a 2-year period.

This surgical technique restored a more physiological elliptical shape to the left ventricle, leading to persistent improvements in heart geometry and function, which were not observed with the circular patch technique used in the STICH trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons from a mathematical hypothesis - modification of the endoventricular circular patch plasty. Adhyapak, SM., Parachuri, VR.[2012]

In the RESTORE clinical registry, myocardial protection during ventricular restoration for congestive heart failure was achieved in 55% of cases using cardioplegia and 45% using a beating heart technique, with the latter being more common in patients with severe heart failure (ejection fraction <30%).

While cardioplegia showed better overall survival rates initially, after adjusting for patient factors like age and ejection fraction, both methods demonstrated comparable outcomes, suggesting that the beating heart technique may be a viable alternative for myocardial protection during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myocardial protection during surgical ventricular restoration. Athanasuleas, C., Siler, W., Buckberg, G.[2007]

Patients with end-stage heart failure can benefit from novel cardiac support strategies like ventricular assist devices (VADs) and cardiac support devices (CSDs), which aim to improve heart function and structure.

While long-term VADs are effective, recovery after removal is rare; however, passive CSDs show promise for reversing heart damage and improving outcomes, particularly after severe heart attacks, though more research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and novel cardiac support therapies. Jugdutt, BI.[2021]

In a study of 51 heart failure patients with reduced ejection fraction, the AccuCinch Transcatheter Left Ventricular Restoration system significantly reduced left ventricular end-diastolic volume by an average of 33.6 mL after 12 months, indicating effective volume reshaping.

Patients also experienced notable improvements in quality of life and exercise endurance, as shown by a 16.4-point increase in Kansas City Cardiomyopathy Questionnaire scores and a 45.9-meter increase in 6-minute walk test distances, with no periprocedural deaths reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Left Ventricular Restoration in Patients With Heart Failure. Hamid, N., Jorde, UP., Reisman, M., et al.[2023]

The Revivent TC™ system is designed to treat heart failure caused by previous heart attacks by reshaping the left ventricle using microanchors to exclude scarred heart tissue.

This innovative procedure, known as Less Invasive Ventricular Enhancement, requires close teamwork between cardiac surgeons and interventional cardiologists to achieve optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal access left ventricular reconstruction. Pillay, T., Neves, P., Benetti, F., et al.[2021]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Device trials in heart failure: a focused summary. [2007]

2. Germany pubmed.ncbi.nlm.nih.gov

The development, evolution, and clinical utilization of artificial heart technology. [2004]

3. Germany pubmed.ncbi.nlm.nih.gov

Lessons from a mathematical hypothesis - modification of the endoventricular circular patch plasty. [2012]

4. Germany pubmed.ncbi.nlm.nih.gov

Myocardial protection during surgical ventricular restoration. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Current and novel cardiac support therapies. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Left Ventricular Restoration in Patients With Heart Failure. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Minimal access left ventricular reconstruction. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the Acorn Cardiac Support Device in animals with heart failure secondary to high rate pacing. [2018]