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Device
AccuCinch® System for Mitral Valve Regurgitation (CorCinch-PMVI Trial)
N/A
Waitlist Available
Led By Kendra Grubb, 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 II-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-PMVI Trial Summary
This trial is testing a new device to treat mitral valve disease in people who have had prior valve surgery.
Who is the study for?
Adults over 18 with moderate to severe mitral regurgitation who've had previous mitral valve repair, are experiencing heart failure symptoms (NYHA II-IV), and have a left ventricular ejection fraction between 20% and 40%. They must be on stable heart failure medication for at least 3 months. Excluded are those with certain allergies, recent strokes or heart attacks, other structural heart diseases, significant untreated coronary artery disease, renal insufficiency, or women who are pregnant.Check my eligibility
What is being tested?
The trial is testing the AccuCinch® Ventricular Restoration System in patients who have previously undergone mitral valve interventions but still suffer from recurrent mitral regurgitation. It's an early-stage study that will observe how well this system works in improving the condition without randomizing participants.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include complications related to device implantation such as bleeding or infection at the access site, allergic reactions to materials in the device like nitinol or polyester if known allergies exist.
CorCinch-PMVI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have heart-related symptoms but can still walk.
Select...
I am 18 years old or older.
CorCinch-PMVI 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-PMVI Trial Design
1Treatment groups
Experimental Treatment
Group I: AccuCinch® Ventricular Restoration SystemExperimental Treatment1 Intervention
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Who is running the clinical trial?
Ancora Heart, Inc.Lead Sponsor
8 Previous Clinical Trials
615 Total Patients Enrolled
6 Trials studying Heart Failure
591 Patients Enrolled for Heart Failure
Kendra Grubb, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
800 Total Patients Enrolled
Guilherme Silva, MDPrincipal InvestigatorBaylor St. Luke's Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any heart surgery or procedures planned in the next 6 months.You had a severe allergic reaction to contrast agents in the past that cannot be prevented with medication.You are expected to live less than 1 year due to non-heart-related health issues.I've been on stable heart failure medication for 3 months, including diuretics, beta-blockers, and ACEi or ARB for 1 month.I have a serious heart artery problem that hasn't been treated with surgery.I cannot walk or carry out any physical activity without discomfort.You are allergic to nitinol, polyester, or polyethylene.I have an ongoing heart infection.I have a heart condition other than dilated cardiomyopathy causing heart failure.I have a serious condition affecting my mitral valve.I have had surgery or a procedure to replace my mitral valve.I am not pregnant, using birth control, or breastfeeding.My kidney function is severely reduced.My body cannot support the AccuCinch® implant due to its structure.I have heart-related symptoms but can still walk.I cannot take blood thinners or anti-clotting medications.Your blood pressure in the arteries of your lungs is consistently too high.Your heart's pumping ability is between 20% and 40%.You have significant calcium build-up or other blockages in your heart or aorta.I have a serious issue with my aortic valve or have an artificial one.I have severe leakage in my heart's tricuspid valve.I am 18 years old or older.I have had a stroke in the last 3 months or have significant disability from a past stroke.I had surgery or a less invasive procedure on my mitral valve over 3 months ago.You had a heart device implanted or replaced in the past three months, or had a defibrillator implanted in the past month.Your condition of FMR is at least moderate, as defined by specific medical guidelines.I am currently on high dose steroids or immunosuppressant therapy.I have not had a heart attack or any heart-related surgery in the last 3 months.I have low blood pressure or need support to maintain my blood circulation.
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 there a plethora of clinical sites administering this trial in the United States?
"This clinical trial is being operated in many locations, such as Cardiovascular Institute of the South in Houma, The Christ Hospital in Cincinnati, and Emory University in Atlanta. An additional 19 sites are registered for this study."
Answered by AI
Are there any available vacancies for this clinical experimentation?
"Unfortunately, clinicaltrials.gov states that recruitment for this trial has concluded. Initially posted on September 24th 2018 and last updated on March 14th 2022, no new patients are being accepted at present; however, there are 916 other medical studies actively seeking volunteers."
Answered by AI
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