2019-06 TRISCEND Study

Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04221490

Enrollment

228

Registered

2020-01-09

Start date

2020-05-06

Completion date

2029-01-31

Last updated

2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation

Keywords

Tricuspid Regurgitation, Transcatheter, Replacement, Functional, Degenerative, Regurgitation, Valve Replacement, Cardiovascular Disease

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.

Interventions

DEVICETranscatheter Tricuspid Valve Replacement

Replacement of the tricuspid valve through a transcatheter approach

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada, France, Switzerland, United States

Contacts

PRINCIPAL_INVESTIGATORSusheel Kodali, MD

Columbia University

Participant flow

Participants by arm

Arm	Count
Edwards EVOQUE Tricuspid Valve Replacement System Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System	228
Total	228

Baseline characteristics

Characteristic	Edwards EVOQUE Tricuspid Valve Replacement System
Age, Continuous	78.5 Years STANDARD_DEVIATION 7.3
NYHA Class Class I	3 Participants
NYHA Class Class II	66 Participants
NYHA Class Class III	152 Participants
NYHA Class Class IV	7 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants
Race/Ethnicity, Customized Asian	16 Participants
Race/Ethnicity, Customized Black or African American	7 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants
Race/Ethnicity, Customized Not Applicable	30 Participants
Race/Ethnicity, Customized Other	9 Participants
Race/Ethnicity, Customized White	165 Participants
Sex: Female, Male Female	162 Participants
Sex: Female, Male Male	66 Participants
Tricuspid Valve Disease Etiology Indeterminate	10 Participants
Tricuspid Valve Disease Etiology Mixed	32 Participants
Tricuspid Valve Disease Etiology Primary (Degenerative, Organic, Structural, or Pacer-related)	27 Participants
Tricuspid Valve Disease Etiology Secondary (Functional or Non-structural)	159 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	23 / 228
other Total, other adverse events	99 / 228
serious Total, serious adverse events	148 / 228

Outcome results

Primary

Clinical Success

Procedural success without MAEs at 30 days.

Time frame: 30 Days

Population: The outcome is reported where data are available.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Edwards EVOQUE Tricuspid Valve Replacement System	Clinical Success	179 Participants

Primary

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

Population: Analysis includes patients who had an MAE or who were followed for at least 30 days. Patients may experience more than one MAE.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Edwards EVOQUE Tricuspid Valve Replacement System	Composite Major Adverse Events (MAEs)	38 Participants

Primary

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

Population: Per device analysis as participants may have more than one device attempted

Arm	Measure	Value (COUNT_OF_UNITS)
Edwards EVOQUE Tricuspid Valve Replacement System	Device Success	218 Device

Primary

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)

Population: The outcome is reported where data are available.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Edwards EVOQUE Tricuspid Valve Replacement System	Procedure Success	212 Participants

Primary

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)

Population: The outcome is reported where data are available.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Edwards EVOQUE Tricuspid Valve Replacement System	Tricuspid Regurgitation Reduction	220 Participants

Secondary