AccuCinch® System for Heart Failure

(CorCinch-HFrEF Trial)

Not currently recruiting at 22 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the AccuCinch® Ventricular Restoration System for individuals with heart failure. The goal is to determine if this system can aid patients with reduced ejection fraction, where the heart's pumping efficiency is compromised. The trial seeks participants experiencing heart failure symptoms that make daily life difficult, despite stable medical treatments. Individuals with a heart condition affecting pumping efficiency, who have been on consistent treatment for at least three months, may qualify.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future heart failure treatments.

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 prior data suggests that the AccuCinch® Ventricular Restoration System is safe for patients with heart failure?

Research has shown that the AccuCinch® Ventricular Restoration System has been safe in earlier studies. Data from two years suggest it can improve heart function without major safety issues. In these studies, patients with heart failure generally tolerated the treatment well. While some side effects occurred, they were neither common nor serious.

This system has been tested in trials with heart failure patients and has demonstrated potential benefits without significant negative effects. For those considering joining a trial with the AccuCinch system, existing research supports its safety in humans. However, discussing any concerns with the study team or a doctor is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AccuCinch® Ventricular Restoration System is unique because it offers a new approach to treating heart failure by specifically targeting the structure of the heart. Unlike standard treatments that often focus on managing symptoms with medications like ACE inhibitors or beta-blockers, AccuCinch® physically reinforces the heart muscle, potentially improving its function and efficiency. Researchers are excited about this treatment because it directly addresses the underlying issue of heart muscle weakness, which could lead to better outcomes for patients with heart failure. This innovative method of mechanically supporting the heart sets it apart from conventional therapies, offering hope for a more effective solution.

What evidence suggests that the AccuCinch® Ventricular Restoration System is effective for heart failure?

Research has shown that the AccuCinch® Ventricular Restoration System, which participants in this trial will receive, can aid individuals with heart failure and a weakened heart pump. Studies have found that this treatment can reshape the left side of the heart, potentially reducing stress on the heart muscle and improving heart function. Data from a previous study reported a significant decrease in hospital visits for heart failure two years after using the device compared to the year before. Additionally, early trials demonstrated a high success rate, with most patients experiencing improvements in their heart condition. Overall, these findings suggest that the AccuCinch® system could effectively manage heart failure symptoms and improve heart health. ^{1 2 3 6 7}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307650/

Reverse Left Ventricular Remodeling With Transcatheter ... The initial pilot study reported a technical success rate of 83% (15/18 patients; the device was explanted in 1 patient) and improvements in ...

2. ancoraheart.com ancoraheart.com/press_releases/ancora-heart-inc-reports-two-year-results/

Ancora Heart Inc. Reports Two-Year Results ... The rate of heart failure hospitalization two years following implant was significantly reduced compared to the year prior to the implant (p< ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04331769

NCT04331769 | Clinical Evaluation of the AccuCinch® ... Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1071916423000702

Transcatheter Left Ventricular Restoration in Patients With ... Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection ...

5. ancoraheart.com ancoraheart.com/physicians-test/

Physicians Test The AccuCinch Ventricular Restoration System is a fundamentally different and innovative device-based therapy designed to improve the structure and function of ...

6. ucihealth.org ucihealth.org/clinical-trials/ccr-24-09

AccuCinch® Ventricular Restoration System/Symptomatic ... The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch ...

7. ancoraheart.com ancoraheart.com/physicians/

AccuCinch Ventricular Restoration System AccuCinch® is the first and only percutaneous ventricular restoration system designed to treat both Heart Failure and FMR.