AccuCinch System for Heart Failure

Recruiting at 126 trial locations

Overseen By Fadi Matar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ancora Heart, Inc.

Must not be taking: High dose steroids

Disqualifiers: Recent MI, Severe RV dysfunction, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the AccuCinch Ventricular Restoration System in patients with a specific type of heart failure. The device helps the heart pump blood more effectively by supporting and reshaping its lower chamber. The study aims to see if this device, combined with standard medical treatment, is safe and effective. The CorCap Cardiac Support Device (CSD) is a predecessor that has shown safety and effectiveness in improving left ventricular structure and function in heart failure patients.

Will I have to stop taking my current medications?

The trial does not specify that you must stop taking your current medications. However, you need to be on stable heart failure medication for at least 30 days before joining the trial, with any changes in medication doses needing a waiting period of 30 days if they exceed certain limits.

What data supports the effectiveness of the AccuCinch Ventricular Restoration System treatment for heart failure?

Research suggests that reshaping the left ventricle (the heart's main pumping chamber) can reduce stress on the heart wall and potentially improve heart function in patients with heart failure. The AccuCinch system uses anchors and a cable to reshape the heart, which may help improve heart performance by reducing its size and stress. ^{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 without the need for open-heart surgery. This minimally invasive approach helps reduce stress on the heart muscle and can improve heart function in patients with heart failure. ^{1 2 4 6 7}

Research Team

Martin B Leon, MD

Principal Investigator

Columbia University

Ulrich P Jorde, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Mark Reisman, MD

Principal Investigator

New York Presbyterian/Weill Cornell Medicine

Eligibility Criteria

This trial is for adults with heart failure and reduced ejection fraction (HFrEF), specifically those who can walk a certain distance, have specific heart size measurements, and are on stable heart failure medication. Excluded are pregnant women, recent stroke or surgery patients, severe valve disease cases, and individuals with allergies to materials in the device.

Inclusion Criteria

My heart failure treatment has been stable for at least 30 days.

I am willing to undergo all required tests, accept blood transfusions if needed, and follow the study schedule.

I can walk between 100 and 450 meters in six minutes.

Exclusion Criteria

I am not pregnant, using birth control, or breastfeeding.

I am currently taking high dose steroids or immunosuppressants.

You are not expected to live more than 1 year because of a non-heart-related health issue.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the AccuCinch Ventricular Restoration System plus guideline-directed medical therapy or guideline-directed medical therapy alone

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 30, 90, 180, 365, 545, and 730 days

Treatment Details

Interventions

• AccuCinch Ventricular Restoration System (Ventricular Restoration System)
• Guideline-Directed Medical Therapy (Drug)

Trial Overview The study tests the AccuCinch Ventricular Restoration System against standard medical therapy for HFrEF. It's an international study where participants are randomly chosen to receive either the new system or continue with their current treatment.

Participant Groups

Group I: Device group: AccuCinch Ventricular Restoration System Experimental Treatment 1 Intervention

Subjects in this arm will receive the AccuCinch Ventricular Restoration System

Group II: Control group: Guideline-Directed Medical Therapy Active Control 1 Intervention

Subjects in this arm will receive guideline-directed medical therapy (GDMT)

Who Is Running the Clinical Trial?

Ancora Heart, Inc.

Lead Sponsor

Trials

9

Recruited

620+

Findings from Research

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]

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]

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]

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 a study of 13,454 adult patients using left ventricular assist devices (LVADs), only 3.1% achieved complete myocardial recovery after 3 years, indicating that recovery is relatively rare but possible.

Factors such as being under 50 years old, having a nonischemic cause of heart failure, and having a left ventricular end-diastolic diameter of less than 6.5 cm significantly increased the likelihood of device explantation for recovery, suggesting that certain patient characteristics can predict recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myocardial Recovery in Patients Receiving Contemporary Left Ventricular Assist Devices: Results From the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Topkara, VK., Garan, AR., Fine, B., et al.[2018]

Ventricular restoration is a promising surgical option for treating heart failure due to ischemic cardiomyopathy, particularly in high-risk patients undergoing coronary artery bypass grafting (CABG).

The combined approach of conventional CABG with mitral valve repair and surgical anterior ventricular restoration (SAVR) has been performed safely in 195 patients, allowing for effective restoration of heart function with minimal reliance on mechanical support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The beating open heart for rebuilding ventricular geometry during surgical anterior restoration. Beyersdorf, F., Doenst, T., Athanasuleas, C., et al.[2019]

The BioVentrix Revivent TC System provides a less invasive alternative for surgical ventricular reconstruction in heart failure patients, eliminating the need for sternotomy, heart-lung machine, and cardioplegic arrest.

This technique effectively reconstructs the left ventricle's shape and volume in patients with postinfarction scars, potentially improving recovery and outcomes compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive left ventricular reconstruction of a postinfarction, anterior left ventricular scar (BioVentrix Revivent TC procedure). Hennig, F., Klein, C., Knosalla, C., et al.[2022]

References

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

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

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

Myocardial protection during surgical ventricular restoration. [2007]

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

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

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

Minimal access left ventricular reconstruction. [2021]

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

Myocardial Recovery in Patients Receiving Contemporary Left Ventricular Assist Devices: Results From the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). [2018]

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

The beating open heart for rebuilding ventricular geometry during surgical anterior restoration. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Minimally invasive left ventricular reconstruction of a postinfarction, anterior left ventricular scar (BioVentrix Revivent TC procedure). [2022]