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Device
AccuCinch® System for Heart Failure (CorCinch-HFrEF Trial)
N/A
Waitlist Available
Led By Ulrich 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
Symptom Status: NYHA III-IV (i.e., ambulatory)
Study patient is at least 18-years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-day
Awards & highlights
CorCinch-HFrEF Trial Summary
This trial is testing a new device to treat heart failure in patients with reduced ejection fraction.
Who is the study for?
Adults with heart failure and reduced ejection fraction (HFrEF), specifically those with a left ventricular diameter ≥55 mm, ejection fraction between 20-40%, and stable on optimal heart failure therapies. Participants must have certain devices like CRT or ICD implanted for specified durations before enrollment, be able to perform diagnostic tests, follow the study schedule, and have NYHA class III-IV symptoms.Check my eligibility
What is being tested?
The trial is testing the AccuCinch® Ventricular Restoration System in patients with HFrEF. It's an early-stage study that's not randomized but is prospective and multi-center. The goal is to see how well this system works in improving heart function by cinching the ventricle.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include complications from device implantation such as bleeding or infection at the access site, allergic reactions to materials used in the device (nitinol, polyester, polyethylene), or worsening of heart function.
CorCinch-HFrEF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have heart issues but can still walk around.
Select...
I am 18 years old or older.
CorCinch-HFrEF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety measured by device-related or procedure-related major adverse events (MAEs)
CorCinch-HFrEF Trial Design
1Treatment groups
Experimental Treatment
Group I: AccuCinch® Ventricular Restoration SystemExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Ancora Heart, Inc.Lead Sponsor
8 Previous Clinical Trials
598 Total Patients Enrolled
6 Trials studying Heart Failure
574 Patients Enrolled for Heart Failure
Michael Zapien, MS, CCRAStudy DirectorAncora Heart, Inc.
3 Previous Clinical Trials
172 Total Patients Enrolled
3 Trials studying Heart Failure
172 Patients Enrolled for Heart Failure
Ulrich Jorde, MDPrincipal InvestigatorMontefiore Medical Center
3 Previous Clinical Trials
70 Total Patients Enrolled
3 Trials studying Heart Failure
70 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart artery disease that hasn't been treated with surgery.My kidney function is severely reduced.I have an ongoing heart infection.You had a heart device implanted or replaced in the last few months.Your heart's ejection fraction is between 20% and 40%.Your heart's left ventricle is too big, with a diameter of 55 millimeters or more.I haven't had a heart attack or any heart-related surgery in the last 3 months.You have moderate to severe mitral regurgitation.I have had surgery or a procedure on my mitral valve.I have low blood pressure or need support to maintain my blood circulation.You have significant dysfunction in the right side of your heart.I have a heart condition other than dilated cardiomyopathy causing heart failure.My body cannot support the AccuCinch® implant due to physical limitations.I have a serious issue with my aortic valve or have an artificial one.You are allergic to nitinol, polyester, or polyethylene.You have a medical condition that is expected to significantly shorten your life.I am currently taking high dose steroids or immunosuppressants.I have heart issues but can still walk around.I have not had a stroke or major disability from a stroke in the last 3 months.I cannot take blood thinners or anti-clotting medications.I've been on stable heart failure treatment for 3 months, with no big dose changes for 1 month.You have a specific heart condition and need to have a certain device in place for at least 3 months.I am 18 years old or older.You had a severe allergic reaction to contrast agents in the past that can't be prevented with medication.I am not pregnant, using birth control, or breastfeeding.I do not have any heart surgery or procedures planned in the next 6 months.I cannot walk or carry out any physical activity without discomfort.I have severe leakage in my heart's tricuspid valve.I had my ICD implanted more than a month ago.You have severe calcification in your aortic arch, or a clot in your heart.
Research Study Groups:
This trial has the following groups:- Group 1: AccuCinch® Ventricular Restoration System
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any more participants being taken into this clinical research study?
"The hosted information on clinicaltrials.gov discloses that this specific trial is not seeking applicants at present; the trial was first advertised on August 23rd 2018 and last updated March 14th 2022. However, there are 830 other medical studies presently enrolling participants."
Answered by AI
To what extent has this trial been implemented across various sites?
"The list of clinical trial sites includes University Hospitals of Cleveland in Cleveland, University of Washington Medicine in Seattle, and The Christ Hospital in Cincinnati. Additionally, there are 19 other medical centres participating."
Answered by AI
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