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Ventricular Restoration System
AccuCinch System for Heart Failure
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
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 belowSelect...
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:Select...
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.
Select...
I have not had a stroke or significant disability from a stroke in the last 3 months.
Select...
My body cannot support the required procedure for AccuCinch implant due to physical limitations.
Select...
My heart valve is significantly narrowed.
Select...
I have moderate to severe aortic regurgitation.
Select...
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
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 moreSecondary 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 moreTrial 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)
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.
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.
Find a Location
Who is running the clinical trial?
Ancora Heart, Inc.Lead Sponsor
8 Previous Clinical Trials
220 Total Patients Enrolled
6 Trials studying Heart Failure
196 Patients Enrolled for Heart Failure
Mark Reisman, MDPrincipal InvestigatorNew York Presbyterian/Weill Cornell Medicine
3 Previous Clinical Trials
1,522 Total Patients Enrolled
Ulrich P Jorde, MDPrincipal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My heart failure treatment has been stable for at least 30 days.My kidney function is very low.My heart's structure or wall thickness is not ideal, based on recent scans.I have not had a heart attack or any heart-related surgery in the last 3 months.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.The size of your heart's left ventricle is larger than 55 millimeters when measured by a special heart ultrasound.I cannot take antiplatelet medication for 90 days.I am 18 years old or older.You have a moderate to severe or severe mitral regurgitation.I have not had a stroke or significant disability from a stroke in the last 3 months.My body cannot support the required procedure for AccuCinch implant due to physical limitations.My CRT device was placed over 90 days ago, and my ICD over 30 days ago, before my heart tests.Your heart's ejection fraction, measured by a special heart ultrasound, is between 20% and 40%.I was diagnosed and treated for heart failure over 3 months ago.You had a severe allergic reaction to contrast agents in the past that cannot be prevented with medication.I have a mild heart valve issue that hasn't required treatment.I have heart failure and have been hospitalized for it in the last year or have difficulty with physical activity.I can walk between 100 and 450 meters in six minutes.My heart valve is significantly narrowed.You have severe tricuspid regurgitation.I have moderate to severe aortic regurgitation.You have had surgery to replace the mitral or aortic valve in your heart before.I cannot take blood thinners during procedures.I have a serious heart artery problem that hasn't been treated with surgery.You have serious calcium buildup in your aortic arch or certain heart conditions that can be seen on special heart imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: Device group: AccuCinch Ventricular Restoration System
- Group 2: Control group: Guideline-Directed Medical Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Heart Failure Patient Testimony for trial: Trial Name: NCT04331769 — N/A
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