Edwards CLASP TR EFS
- Conditions
- Tricuspid Regurgitation
- Interventions
- Device: Edwards PASCAL Transcatheter Valve Repair System
- Registration Number
- NCT03745313
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
- Detailed Description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 65
- Severe functional or degenerative TR
- Symptomatic despite medical therapy
- The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair
- Unsuitable anatomy
- Previous tricuspid valve repair or replacement
- Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Edwards PASCAL Transcatheter Valve Repair System Treatment with the Edwards PASCAL Transcatheter Valve Repair System
- Primary Outcome Measures
Name Time Method Composite Major Adverse Event (MAE) Rate 30 days Number and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days.
- Secondary Outcome Measures
Name Time Method Device Success Intraprocedural Number and percentage of Device Success, definition modified from MVARC criteria. Per device analysis
Procedural Success Discharge (2-7 days) Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis
Clinical Success 30 days Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis
Trial Locations
- Locations (15)
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
St. Vincent Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Columbia University Medical Center/New York Presbyterian Hospital
🇺🇸New York, New York, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
NYU Langone Health
🇺🇸New York, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States