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Annuloplasty Ring
Percutaneous Ring Annuloplasty for Tricuspid Regurgitation
N/A
Recruiting
Research Sponsored by Cardiac Implants LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
New York Heart Associate Classification ≥ II.
Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-adjustment
Awards & highlights
Study Summary
This trial is testing a new device to treat tricuspid regurgitation, a heart valve disease. The device is implanted using a catheter, a thin tube inserted through a vein. The study will evaluate the safety and effectiveness of the device, as well as how well it works after being adjusted about 90 days after implantation.
Who is the study for?
Adults over 18 with moderate to severe functional tricuspid regurgitation, a heart condition where the valve doesn't close tightly. They must have a left ventricular ejection fraction of at least 30%, suitable anatomy for the device, and be able to follow study procedures. Excluded are those with recent heart failure hospitalization, severe right ventricle issues, high lung artery pressure, or other conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing a new Cardiac Implants Percutaneous Ring Annuloplasty System designed for people suffering from significant tricuspid valve leakage. It involves placing an annuloplasty ring via catheter and adjusting it after about three months to see if it improves heart function.See study design
What are the potential side effects?
Potential side effects may include complications related to catheter insertion such as bleeding or infection, adverse reactions to materials in the device like stainless steel or nitinol, and possible interference with existing pacemaker or defibrillator leads.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition limits my physical activity.
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My heart valve issue is moderate to severe, as per specific guidelines.
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I am 18 years old or older.
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I still have symptoms of heart failure despite taking all my medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-adjustment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-adjustment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from device or procedure-related mortality
Secondary outcome measures
Functional: Changes in Distance Walked for Exercise Tolerance
Functional: Changes in NYHA Classification
Functional: Changes in Quality of Life Scores and Sub-Domains
+20 moreOther outcome measures
Changes in Heart Failure Biomarkers
Freedom from Heart Failure Events
Trial Design
1Treatment groups
Experimental Treatment
Group I: CI Percutaneous Ring Annuloplasty SystemExperimental Treatment1 Intervention
Patients treated with the CI Percutaneous Ring Annuloplasty System
Find a Location
Who is running the clinical trial?
Cardiac Implants LLCLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
Noa Avisar, PhDStudy DirectorCardiac Implants LLC
2 Previous Clinical Trials
260 Total Patients Enrolled
Nodar Kipshidze, MPHStudy DirectorCardiac Implants LLC
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe heart valve issues.I have not had a stroke in the last 3 months.Your tricuspid valve is tethered more than 10 millimeters.You don't have a suitable vein in your neck for the study procedure.I have acute anemia.I have had bleeding issues or stomach ulcers in the last 3 months.You have had a heart transplant in the past.My heart's tricuspid valve can't be seen clearly for the procedure.I cannot undergo heart imaging tests through my chest or esophagus.My heart condition limits my physical activity.You have a pacemaker or defibrillator leads in your heart that could get in the way of the procedure, as determined by an echocardiogram.I am not on IV drugs to support my heart function.My heart valve issue is moderate to severe, as per specific guidelines.I have been taking oral steroids for 6 months or more.Your heart's blood pressure in the lungs is measured to be higher than 70 mmHg with a specific test called Transthoracic Echocardiography.I cannot take blood thinners or certain heart medications.My heart valve issue is due to a natural cause like infection or a birth defect.I have not had a severe infection or endocarditis in the last year.A team of heart specialists agrees that a specific heart valve procedure is a good option for me.Your heart's pumping ability (LVEF) is above 30% within 90 days before the procedure.Your tricuspid valve is larger than 40mm or more than 21 mm/m2 based on a heart ultrasound taken within 90 days before the procedure.I am currently being treated for a clot or mass in my heart.I have a narrowed tricuspid valve in my heart.You are allergic to contrast dye, stainless steel, or nitinol and cannot take medicine to prevent an allergic reaction.I am not pregnant or breastfeeding.I have not had a heart attack or heart procedure in the last 60 days.I was hospitalized for worsening heart failure within the last 4 weeks.Your heart's right ventricle is severely not working well, as checked by a heart ultrasound.I need another heart procedure around the time of my current treatment.I have had a pulmonary embolism in the past 6 months.I cannot or will not receive blood transfusions.I am 18 years old or older.I have had surgery on my tricuspid valve before.I have severe kidney problems or am on dialysis.I still have symptoms of heart failure despite taking all my medications.
Research Study Groups:
This trial has the following groups:- Group 1: CI Percutaneous Ring Annuloplasty 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 currently any vacancies for participants in this trial?
"Affirmative, the information posted on clinicaltrials.gov signals that this medical research is open to participants. The trial was established in December 2021 and updated last month, with a target of 15 enrollees between 2 centres."
Answered by AI
How many participants are being welcomed into this research endeavor?
"Affirmative, clinicaltrials.gov attests that this study is recruiting participants since its initial posting on December 1st 2021 and the most recent update was made November 18th 2021. 15 volunteers are required from 2 different locations to complete the trial's requirements."
Answered by AI
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