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2019-06 TRISCEND Study

Primary Purpose

Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transcatheter Tricuspid Valve Replacement
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Valve Regurgitation focused on measuring Tricuspid Regurgitation, Transcatheter, Replacement, Functional, Degenerative, Regurgitation, Valve Replacement, Cardiovascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Stanford University
  • Emory University
  • Piedmont Heart Institute
  • Northwestern University
  • University of Maryland
  • Massachusetts General Hospital Boston
  • Brigham and Women's Hospital
  • Henry Ford Hospital
  • Morristown Medical Center
  • Montefiore Medical Center
  • Columbia University Irving Medical Center / NYPH
  • Cleveland Clinic
  • Oregon Health & Science University
  • Hospital of the University of Pennsylvania
  • Baylor Heart Hopsital Plano
  • Intermountain Medical Center
  • University of Virginia Health System
  • St. Paul's Hospital VancouverRecruiting
  • St. Michael's HospitalRecruiting
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)Recruiting
  • CHU Bordeaux, Hôpital Cardiologique Haut Lévêque
  • Clinique Pasteur
  • InselSpital University Hospital Bern
  • Universitätsspital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System

Outcomes

Primary Outcome Measures

Freedom from device or procedure-related adverse events [Time Frame: 30 days]
Freedom from device or procedure-related adverse events

Secondary Outcome Measures

NYHA Functional Class
Number of patients with improvement in NYHA class
Six minute walk test
Change in distance (m) from baseline
Reduction in TR grade
Number of patients with reduction in TR from baseline
Health Status - KCCQ
Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire
Health Status - SF-36
Number of points of improvement in health status as measured by 36 item short form survey (SF-36)

Full Information

First Posted
January 6, 2020
Last Updated
July 6, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT04221490
Brief Title
2019-06 TRISCEND Study
Official Title
Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
Keywords
Tricuspid Regurgitation, Transcatheter, Replacement, Functional, Degenerative, Regurgitation, Valve Replacement, Cardiovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
Intervention Type
Device
Intervention Name(s)
Transcatheter Tricuspid Valve Replacement
Other Intervention Name(s)
Edwards EVOQUE Tricuspid Valve Replacement System
Intervention Description
Replacement of the tricuspid valve through a transcatheter approach
Primary Outcome Measure Information:
Title
Freedom from device or procedure-related adverse events [Time Frame: 30 days]
Description
Freedom from device or procedure-related adverse events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
NYHA Functional Class
Description
Number of patients with improvement in NYHA class
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Six minute walk test
Description
Change in distance (m) from baseline
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Reduction in TR grade
Description
Number of patients with reduction in TR from baseline
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Health Status - KCCQ
Description
Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire
Time Frame
30 days, 6 months, 12 months, annual for five years
Title
Health Status - SF-36
Description
Number of points of improvement in health status as measured by 36 item short form survey (SF-36)
Time Frame
30 days, 6 months, 12 months, annual for five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TMTT Clinical
Phone
949-250-2500
Email
TMTT_Clinical@Edwards.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susheel Kodali, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Massachusetts General Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Withdrawn
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Columbia University Irving Medical Center / NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Baylor Heart Hopsital Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. Paul's Hospital Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia VanHoof
Phone
604-682-2344
Ext
64985
Email
CVanHoof@providencehealth.bc.ca
First Name & Middle Initial & Last Name & Degree
Elizabeth Grieve
Phone
604 682 2344
Ext
64980
Email
egrieve@providencehealth.bc.ca
First Name & Middle Initial & Last Name & Degree
John Webb, MD
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivana Kandic
Phone
416-360-4000
Ext
43003
Email
ivana.kandic@unityhealh.to
First Name & Middle Initial & Last Name & Degree
Alana Harrington
Phone
416-360-4000
Ext
49003
Email
alana.harrington@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Neil Fam, MD
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Lachance
Phone
418-656-8711
Ext
3055
Email
dominique.lachance@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Shirley Baril
Phone
418-656-8711
Ext
4129
Email
shirley.baril@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Josep Rodés-Cabau, MD
Facility Name
CHU Bordeaux, Hôpital Cardiologique Haut Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Individual Site Status
Active, not recruiting
Facility Name
InselSpital University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
CH-8091
Country
Switzerland
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

2019-06 TRISCEND Study

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