Actively Recruiting
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System for Treating Functional Tricuspid Regurgitation
Led by Cardiac Implants LLC · Updated on 2021-11-30
15
Participants Needed
2
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing the safety and performance of the Cardiac Implants Percutaneous Ring Annuloplasty System in adults with moderate or greater functional tricuspid regurgitation (FTR). This early feasibility trial aims to evaluate the transcatheter delivery and implantation of a flexible annuloplasty ring and its adjustment about 90 days later to improve heart valve function. The study also looks at changes in heart function and quality of life after treatment. The procedure involves delivering the ring through a catheter inserted via the right internal jugular vein, guided by fluoroscopy and echocardiography. After the ring is implanted and becomes embedded in heart tissue, it is manually adjusted three months later to achieve the desired valve tightening, with a fastener securing it in place. The study is single-arm and non-randomized, with all participants receiving the investigational device. Participants will undergo multiple evaluations including imaging scans, heart function tests, and quality of life assessments over several years. Safety and technical success are monitored at various time points up to five years after adjustment. The primary outcome is freedom from device or procedure-related death 30 days after the ring adjustment. Follow-up includes checks for adverse events, valve function changes, and exercise tolerance.
CONDITIONS
Brief Title
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate to severe functional tricuspid regurgitation as defined by specific heart imaging guidelines
- Tricuspid valve annular diameter of 40 mm or greater (or more than 21 mm/m2) measured within 90 days before the implant
- Age 18 years or older at enrollment
- New York Heart Association Classification II or higher
- Symptoms of right heart failure despite optimized medical treatment
- Agreement by a multidisciplinary heart team that percutaneous annuloplasty is appropriate
- Left ventricular ejection fraction 30% or higher within 90 days before the implant
- Suitable heart anatomy for device implantation
- Signed informed consent before any study procedures
- Willingness and ability to comply with all follow-up evaluations and assessments
You will not qualify if you...
- Acute decompensated heart failure requiring hospital admission within 4 weeks before enrollment
- Severe right ventricular dysfunction as seen on echocardiography
- Primary tricuspid valve disease such as rheumatic, congenital, or infective causes
- Participation in another investigational drug or device study
- Systolic pulmonary arterial pressure greater than 70 mmHg
- Need for additional cardiac procedures near the time of the implant
- Tricuspid valve stenosis
- Moderate or worse disease of aortic, mitral, or pulmonic valves
- Presence of intracardiac thrombus, mass, or infection requiring treatment
- Previous tricuspid valve repair or replacement
- Allergies to contrast media, stainless steel, or nitinol that cannot be managed
- History of heart transplantation
- Contraindications to echocardiographic imaging
- Endocarditis or severe infection within 12 months before implant
- Recent heart attack, coronary intervention, or unstable angina within 60 days
- Stroke within the previous 3 months
- Hemodynamic instability or use of intravenous inotropes
- Contraindications to anticoagulant or dual antiplatelet therapy
- History of bleeding disorders, active peptic ulcer, or gastrointestinal bleeding in past 3 months
- Severe kidney disease or dialysis
- Conditions limiting study completion or compliance, including life expectancy less than 1 year
- Acute anemia
- Chronic oral steroid use for 6 months or more
- Pregnant or breastfeeding females with positive pregnancy test before radiation exposure
- Pulmonary embolism within last 6 months
- Tricuspid valve tethering distance over 10 mm
- Immobile or interfering pacemaker or defibrillator leads
- Inadequate imaging window for the procedure
- Contraindications or refusal for blood transfusions
- Emergency treatment required
- Lack of appropriate jugular vein access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 day
Participants undergo implantation of the CI Percutaneous Ring Annuloplasty System through a minimally invasive catheter procedure.
1 implantation visit (in-person)
Duration - Occurs around 3 months after implantation
Participants receive an adjustment of the implanted ring approximately 3 months after implantation to optimize tricuspid valve function.
1 adjustment visit (in-person)
Duration - Up to 5 years post-adjustment
Participants are monitored for safety, device performance, and functional outcomes with periodic assessments up to 5 years post-adjustment.
Multiple follow-up visits at 30, 60, and 90 days post-implant; and 30 days, 3 months, 6 months, 12 months, and annually up to 5 years post-adjustment
Trial Site Locations
Total: 2 locations
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
2
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
Research Team
N
Nodar Kipshidze, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here