2019-06 TRISCEND Study
- Conditions
- Cardiovascular DiseasesTricuspid Valve RegurgitationHeart Valve Diseases
- Interventions
- Device: Transcatheter Tricuspid Valve Replacement
- Registration Number
- NCT04221490
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
- Detailed Description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 228
- Functional or degenerative TR moderate or greater
- Symptomatic despite medical therapy or prior HF hospitalization from TR
- The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
Key
- Tricuspid valve anatomic contraindications
- Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
- Hemodynamic instability
- Refractory heart failure requiring advanced intervention
- Currently participating in another investigational study in which the patient has not reached a primary endpoint
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Transcatheter Tricuspid Valve Replacement Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
- Primary Outcome Measures
Name Time Method Composite Major Adverse Events (MAEs) 30 Days Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.
Device Success Intraprocedural Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
Procedure Success Discharge (Up to 7 days post procedure) Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.
Clinical Success 30 Days Procedural success without MAEs at 30 days.
Tricuspid Regurgitation Reduction Discharge (Up to 7 days post procedure) Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.
- Secondary Outcome Measures
Name Time Method Tricuspid Regurgitation (TR) Grade Baseline, 30 Days, 6 Months Tricuspid regurgitation (TR) is measured by transthoracic echocardiogram (TTE) at each visit using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.
New York Heart Association (NYHA) Functional Class Baseline, 30 Days, 6 Months NYHA Functional Classification - The stages of heart failure:
Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest.Change in Six Minute Walk Test (6WMT) Distance 30 Days, 6 Months Mean distance in meters walked during Six Minute Walk Test (6MWT) at each follow-up visit compared to baseline. 6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.
Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) 30 Days, 6 Months Mean KCCQ score at each follow-up visit compared to baseline. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score 30 Days, 6 Months Mean change in SF-36 mental score at each follow-up visit compared to baseline compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score 30 Days, 6 Months Mean change in SF-36 physical score at each follow-up visit compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Change in Body Weight 30 Days, 6 Months Mean change in body weight in kilograms at each follow-up visit compared to baseline.
Change in Left Ankle Circumference 30 Days, 6 Months Mean change in left ankle circumference in centimeters at each follow-up visit compared to baseline.
Change in Right Ankle Circumference 30 Days, 6 Months Mean change in right ankle circumference in centimeters at each follow-up visit compared to baseline.
Edema Assessment By Visit Baseline, 30 Days, 6 Months The edema grading scale measures how quickly the dimple goes back to normal (rebound) after a pitting test. The scale includes:
Grade 1: Immediate rebound with 0 to 2 millimeter (mm) pit. Grade 2: Less than 15-second rebound with 3 to 4 mm pit. Grade 3: Rebound greater than 15 seconds but less than 60 seconds with 5 to 6 mm pit.
Grade 4: Rebound between 2 to 3 minutes with an 8 mm pit.
Trial Locations
- Locations (20)
Massachusetts General Hospital Boston
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Columbia University Irving Medical Center / NYPH
🇺🇸New York, New York, United States
Baylor Heart Hopsital Plano
🇺🇸Plano, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
St. Paul's Hospital Vancouver
🇨🇦Vancouver, British Columbia, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)
🇨🇦Québec, Canada
CHU Bordeaux, Hôpital Cardiologique Haut Lévêque
🇫🇷Pessac, France
Clinique Pasteur
🇫🇷Toulouse, France
InselSpital University Hospital Bern
🇨🇭Bern, Switzerland
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Stanford, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States