2019-06 TRISCEND Study

N/AActive Not RecruitingNCT04221490

Edwards Lifesciences228 enrolled

Overview

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

228

Conditions

Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases

Interventions

Transcatheter Tricuspid Valve ReplacementDEVICE

Replacement of the tricuspid valve through a transcatheter approach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (20)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Stanford University

Outcomes

Primary Outcomes

Composite Major Adverse Events (MAEs)

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.

Time frame: 30 Days

Device Success

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.

Time frame: Intraprocedural

Procedure Success

Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.

Time frame: Discharge (Up to 7 days post procedure)

Clinical Success

Procedural success without MAEs at 30 days.

Time frame: 30 Days

Tricuspid Regurgitation Reduction

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.

Time frame: Discharge (Up to 7 days post procedure)

Secondary Outcomes

Tricuspid Regurgitation (TR) Grade

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.

Data from ClinicalTrials.gov

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Stanford, California, United States

Emory University

Atlanta, Georgia, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Northwestern University

Evanston, Illinois, United States

Massachusetts General Hospital Boston

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Columbia University Irving Medical Center / NYPH

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

...and 10 more locations

Time frame: Baseline, 30 Days, 6 Months

New York Heart Association (NYHA) Functional Class

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.

Time frame: Baseline, 30 Days, 6 Months

Change in Six Minute Walk Test (6WMT) Distance

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.

Time frame: 30 Days, 6 Months

Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

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.

Time frame: 30 Days, 6 Months

Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score

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.

Time frame: 30 Days, 6 Months

Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score

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.

Time frame: 30 Days, 6 Months

Change in Body Weight

Mean change in body weight in kilograms at each follow-up visit compared to baseline.

Time frame: 30 Days, 6 Months

Change in Left Ankle Circumference

Mean change in left ankle circumference in centimeters at each follow-up visit compared to baseline.

Time frame: 30 Days, 6 Months

Change in Right Ankle Circumference

Mean change in right ankle circumference in centimeters at each follow-up visit compared to baseline.

Time frame: 30 Days, 6 Months

Edema Assessment By Visit

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.

Time frame: Baseline, 30 Days, 6 Months