Brief Summary
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
Brief Title
2019-06 TRISCEND Study
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Tricuspid Valve Regurgitation
Heart Valve Diseases
Cardiovascular Diseases
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Tricuspid Regurgitation
Transcatheter
Replacement
Functional
Degenerative
Regurgitation
Valve Replacement
Cardiovascular Disease
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04221490
Org Class
Industry
Org Full Name
Edwards Lifesciences
Org Study Id
2019-06
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
Primary Outcomes
Outcome Description
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.
Outcome Measure
Composite Major Adverse Events (MAEs)
Outcome Time Frame
30 Days
Outcome Description
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.
Outcome Measure
Device Success
Outcome Time Frame
Intraprocedural
Outcome Description
Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.
Outcome Measure
Procedure Success
Outcome Time Frame
Discharge (Up to 7 days post procedure)
Outcome Description
Procedural success without MAEs at 30 days.
Outcome Measure
Clinical Success
Outcome Time Frame
30 Days
Outcome Description
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.
Outcome Measure
Tricuspid Regurgitation Reduction
Outcome Time Frame
Discharge (Up to 7 days post procedure)
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline, 30 Days, 6 Months
Outcome Measure
Tricuspid Regurgitation (TR) Grade
Outcome Description
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.
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.
Outcome Time Frame
Baseline, 30 Days, 6 Months
Outcome Measure
New York Heart Association (NYHA) Functional Class
Outcome Description
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.
Outcome Time Frame
30 Days, 6 Months
Outcome Measure
Change in Six Minute Walk Test (6WMT) Distance
Outcome Description
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.
Outcome Time Frame
30 Days, 6 Months
Outcome Measure
Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Outcome Description
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.
Outcome Time Frame
30 Days, 6 Months
Outcome Measure
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score
Outcome Description
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.
Outcome Time Frame
30 Days, 6 Months
Outcome Measure
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score
Outcome Description
Mean change in body weight in kilograms at each follow-up visit compared to baseline.
Outcome Time Frame
30 Days, 6 Months
Outcome Measure
Change in Body Weight
Outcome Description
Mean change in left ankle circumference in centimeters at each follow-up visit compared to baseline.
Outcome Time Frame
30 Days, 6 Months
Outcome Measure
Change in Left Ankle Circumference
Outcome Description
Mean change in right ankle circumference in centimeters at each follow-up visit compared to baseline.
Outcome Time Frame
30 Days, 6 Months
Outcome Measure
Change in Right Ankle Circumference
Outcome Description
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.
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.
Outcome Time Frame
Baseline, 30 Days, 6 Months
Outcome Measure
Edema Assessment By Visit
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076