Actively Recruiting
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
Led by Cardiac Implants LLC · Updated on 2021-11-30
15
Participants Needed
2
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).
CONDITIONS
Official 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 according to ASE and European guidelines
- Tricuspid valve annular diameter 40mm or greater, or over 21 mm/m2 measured by echocardiogram within 90 days before implantation
- Age 18 years or older at enrollment
- New York Heart Association Classification II or higher
- Symptoms of right heart failure despite optimized medical therapy
- Agreement by a multidisciplinary heart team that percutaneous tricuspid annuloplasty is appropriate
- Left ventricular ejection fraction 30% or higher within 90 days prior to implantation
- Suitable anatomy for device implantation based on imaging
- Signed informed consent before study procedures
- Willingness and ability to comply with follow-up assessments
You will not qualify if you...
- Acute decompensated heart failure requiring hospitalization within 4 weeks before enrollment
- Severe right ventricular dysfunction seen on echocardiography
- Primary (organic) tricuspid valve disease such as rheumatic, congenital, or infective causes
- Current participation in another investigational drug or device study
- Systolic pulmonary arterial pressure over 70 mmHg measured by echocardiogram
- Need for another cardiac procedure during the study period or within 30 days before or after
- Tricuspid valve stenosis
- More than moderate aortic, mitral, or pulmonic valve stenosis or regurgitation
- Presence of intracardiac thrombus, mass, or vegetation requiring treatment
- Previous tricuspid valve repair or replacement
- Known allergy to contrast media, stainless steel, or nitinol that cannot be managed
- History of cardiac transplantation
- Contraindications to transthoracic or transesophageal echocardiography
- Endocarditis or severe infection within 12 months prior to implantation
- Myocardial infarction, percutaneous coronary intervention, or unstable angina within 60 days before implantation
- Stroke within the previous 3 months
- Hemodynamic instability or use of intravenous inotropes
- Contraindications to anticoagulant and dual antiplatelet therapies
- History of bleeding disorders or active gastrointestinal bleeding within 3 months
- Severe kidney impairment or dialysis
- Conditions limiting study completion or compliance, such as life expectancy under 1 year
- Acute anemia
- Chronic oral steroid use of 6 months or longer
- Pregnant or lactating females with positive pregnancy test before radiation exposure
- Pulmonary embolism within the last 6 months
- Tricuspid valve tethering distance greater than 10 mm
- Presence of immobile or interfering transvalvular pacemaker or defibrillator leads
- Inadequate imaging window for guiding implantation
- Contraindications to blood transfusion or refusal of transfusion
- Emergency treatment at enrollment
- Lack of appropriate jugular vein access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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