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Ventricular Restoration System

AccuCinch System for Heart Failure

N/A
Recruiting
Led By Ulrich P Jorde, 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
Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented
Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Awards & highlights

Study Summary

This trial is testing a new device to help people with heart failure. The device is placed around the heart to help it pump better. The trial will test how well the device works and if it is safe.

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.Check my eligibility
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.See study design
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
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My heart failure treatment has been stable for at least 30 days.
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I am willing to undergo all required tests, accept blood transfusions if needed, and follow the study schedule.
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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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My CRT device was placed over 90 days ago, and my ICD over 30 days ago, before my heart tests.
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I was diagnosed and treated for heart failure over 3 months ago.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Changes from baseline in 6-Minute Walk Test (6MWT)
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Changes from baseline in New York Heart Association (NYHA) functional class
+13 more
Other outcome measures
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 left atrial strain measured by Echo
+6 more

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)

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
Martin B Leon, MDStudy ChairColumbia University
11 Previous Clinical Trials
10,738 Total Patients Enrolled
Ulrich P Jorde, MDPrincipal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine

Media Library

AccuCinch Ventricular Restoration System (Ventricular Restoration System) Clinical Trial Eligibility Overview. Trial Name: NCT04331769 — N/A
Heart Failure Research Study Groups: Device group: AccuCinch Ventricular Restoration System, Control group: Guideline-Directed Medical Therapy
Heart Failure Clinical Trial 2023: AccuCinch Ventricular Restoration System Highlights & Side Effects. Trial Name: NCT04331769 — N/A
AccuCinch Ventricular Restoration System (Ventricular Restoration System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04331769 — N/A
Heart Failure Patient Testimony for trial: Trial Name: NCT04331769 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still patient openings for this experiment?

"Affirmative. According to the information listed on clinicaltrials.gov, this medical trial is actively accruing participants after being initially posted on December 21th 2020 and lastly updated November 7th 2022. The study requires 400 patients from 80 sites around the globe."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Louisiana
What site did they apply to?
Cardiovascular Institute of the South
Jackson Heart Clinic
Baptist Health Heart Failure & Transplant Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2

Why did patients apply to this trial?

My Cholesterol levels are High.
PatientReceived 2+ prior treatments
~19 spots leftby Jun 2024