AccuCinch System for Heart Failure

Recruiting at 126 trial locations

Overseen By Fadi Matar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ancora Heart, Inc.

Must not be taking: High dose steroids

Disqualifiers: Recent MI, Severe RV dysfunction, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 6 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the AccuCinch Ventricular Restoration System, to determine its effectiveness for individuals with heart failure and reduced ejection fraction (a measure of heart pumping efficiency). The study compares the device to standard medical treatments to assess safety and effectiveness. Individuals diagnosed with heart failure for at least 90 days, meeting specific heart function criteria, and on stable heart medications may qualify for this trial. As an unphased trial, it provides participants the chance to contribute to groundbreaking research that could enhance heart failure treatments.

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

Research has shown that the AccuCinch Ventricular Restoration System holds promise for safety in people with heart failure. In earlier studies, patients using this device experienced significant improvements in heart function. Reports over two years indicate that the device is well-tolerated, with no major safety issues identified.

The device reshapes the heart's lower chamber, enhancing heart function. Improvements in symptoms and overall heart health were also observed. While more research is needed, current data suggests that the AccuCinch system is safe for people with heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AccuCinch Ventricular Restoration System is unique because it offers a mechanical approach to treating heart failure, unlike standard options like medications or cardiac resynchronization therapy. This device directly targets the heart's structure by cinching the weakened ventricular wall, which could improve heart function more effectively than conventional treatments. Researchers are excited because this method might provide a new way to strengthen the heart and enhance patients' quality of life, offering hope for those who may not respond well to existing therapies.

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

In this trial, participants will join one of two groups. The AccuCinch Ventricular Restoration System, which some participants will receive, may benefit individuals with heart failure and a reduced ejection fraction, indicating their heart isn't pumping effectively. Studies have found that this device can help the heart reshape and function better. Specifically, after two years, patients using the device experienced improvements in symptoms and overall heart function. The system works by reducing the size of the left ventricle and decreasing stress on its walls. Overall, the AccuCinch System has shown positive results in improving heart health and reducing heart failure symptoms. ^{1 3 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• AccuCinch Ventricular Restoration System
• Guideline-Directed Medical Therapy

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.

How Is the Trial Designed?

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)

AccuCinch Ventricular Restoration System is already approved in United States, European Union for the following indications:

Approved in United States as AccuCinch Ventricular Restoration System for:

• Investigational use only; no approved indications yet

Approved in European Union as AccuCinch Ventricular Restoration System for:

• Investigational use only; no approved indications yet

Who Is Running the Clinical Trial?

Ancora Heart, Inc.

Lead Sponsor

Trials

9

Recruited

620+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

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

Ancora Heart Inc. Reports Two-Year Results ... “These two-year data reinforce that the AccuCinch System has the potential to deliver meaningful and sustained reverse remodeling of the heart,” ...

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

Transcatheter Left Ventricular Restoration in Patients With ... The AccuCinch Transcatheter Left Ventricular Restoration system is designed for patients with heart failure and dilated left ventricle (A). The device creates ...

3. massdevice.com massdevice.com/ancora-heart-positive-2-year-accucinch-data/

Ancora Heart reports positive 2-year AccuCinch data Key outcomes included sustained reverse remodeling, improvements in functional status and symptoms and a significantly reduced rate of heart ...

4. 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 ...

5. cardiovascularbusiness.com cardiovascularbusiness.com/topics/clinical/heart-failure/first-250-patients-enrolled-transcatheter-heart-failure-device-trial-reduce-lv-size

First 250 patients enrolled in transcatheter heart failure ... The AccuCinch System is an investigational device designed to reduce the size of the left ventricle, reduce ventricular wall stress, and support ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03183895

Study Details | NCT03183895 | Evaluate the Safety and ... The primary objectives of this study are to evaluate the safety and performance of the AccuCinch Ventricular Repair System for the treatment of heart failure ...