What side effects are associated with this type of intervention?

Common treatments for heart failure that involve ventricular remodeling and reduction, such as the AccuCinch Ventricular Restoration System, include ventricular reduction/remodeling surgery, mitral valve repair, mechanical ventricular assist devices (VADs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT). Known side effects of these treatments can include infection, bleeding, thromboembolic events, device malfunction, and complications related to surgery such as wound healing issues. Additionally, patients may experience arrhythmias, renal impairment, and adverse reactions to anesthesia.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that aim to improve heart function by addressing the mechanical properties or shape of the left ventricle. Cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs) are notable examples, as they help improve ventricular synchrony and prevent sudden cardiac death. Additionally, pharmacological treatments such as ACE inhibitors, beta-blockers, and angiotensin receptor blockers have been approved to manage heart failure symptoms and improve overall heart function. The AccuCinch Ventricular Restoration System, which reshapes and reduces the size of the left ventricle, represents a novel approach in this therapeutic landscape.

What other types of research exist?

Promising alternatives to the AccuCinch Ventricular Restoration System for heart failure patients include the CorCap cardiac support device, which reduces ventricular wall stress and has shown long-term benefits in reducing ventricular remodeling. Additionally, off-pump epicardial ventricular reconstruction has demonstrated the ability to restore left ventricular twist and reverse remodeling in preclinical models. Both therapies offer less invasive options and have shown potential in improving heart function.

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Ventricular Restoration System

AccuCinch System for Heart Failure

Q: What is the mechanism of action of this treatment?

Common treatments for Heart Failure (HF) aim to improve heart function, alleviate symptoms, and slow disease progression. The AccuCinch Ventricular Restoration System, which reshapes and reduces the size of the left ventricle, works by improving the mechanical efficiency of the heart. This is similar to other structural interventions like cardiac resynchronization therapy (CRT) and mitral valve repair, which enhance cardiac output and reduce ventricular stress. These treatments are crucial for HF patients as they directly address the heart's impaired ability to pump blood, thereby improving quality of life and reducing the risk of hospitalization and mortality.

N/A

Recruiting

Led By Mark Reisman, MD

Research Sponsored by Ancora Heart, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to complete six-minute walk test with distance between 100 m and 450 m

Age 18-years or older

Must not have

Subjects on high dose steroids or immunosuppressant therapy

Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days, 90 days, 180 days, 365 days, 545 days, 730 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications from device implantation such as bleeding or infection, allergic reactions to device materials like nitinol or polyester, and possible need for blood transfusions during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

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I am 18 years old or older.

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I have heart failure and have been hospitalized for it in the last year or have difficulty with physical activity.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking high dose steroids or immunosuppressants.

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My kidney function is very low.

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My heart's structure or wall thickness is not ideal, based on recent scans.

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I cannot take antiplatelet medication for 90 days.

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

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I have not had a stroke or significant disability from a stroke in the last 3 months.

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My body cannot support the required procedure for AccuCinch implant due to physical limitations.

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My heart valve is significantly narrowed.

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I have moderate to severe aortic regurgitation.

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I cannot take blood thinners during procedures.

Select...

I have a serious heart artery problem that hasn't been treated with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 90 days, 180 days, 365 days, 545 days, 730 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 90 days, 180 days, 365 days, 545 days, 730 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 90 days, 180 days, 365 days, 545 days, 730 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-Minute Walk Test (6MWT) distance (m)

A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)

Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score

+1 more

Secondary study objectives

Changes from baseline in 6-Minute Walk Test (6MWT)

Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)

Other study objectives

Changes from baseline in EuroQol Five Dimension Five Level (EQ-5D-5L) Quality of Life Questionnaire

Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains

Changes from baseline in right ventricular (RV) fractional area change measured by Echo

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Device group: AccuCinch Ventricular Restoration SystemExperimental Treatment1 Intervention

Subjects in this arm will receive the AccuCinch Ventricular Restoration System

Group II: Control group: Guideline-Directed Medical TherapyActive Control1 Intervention

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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Heart Failure (HF) aim to improve heart function, alleviate symptoms, and slow disease progression. The AccuCinch Ventricular Restoration System, which reshapes and reduces the size of the left ventricle, works by improving the mechanical efficiency of the heart. This is similar to other structural interventions like cardiac resynchronization therapy (CRT) and mitral valve repair, which enhance cardiac output and reduce ventricular stress. These treatments are crucial for HF patients as they directly address the heart's impaired ability to pump blood, thereby improving quality of life and reducing the risk of hospitalization and mortality.

MitraClip Therapy for Mitral Regurgitation: Secondary Mitral Regurgitation.Effects of adaptive servo-ventilation therapy on cardiac function and remodeling in patients with chronic heart failure (SAVIOR-C): study protocol for a randomized controlled trial.