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Edwards CLASP TR EFS (CLASP TR EFS)

Primary Purpose

Tricuspid Regurgitation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Edwards PASCAL Transcatheter Valve Repair System
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring Functional, TR, FTR, Transcatheter, Repair, Regurgitation, Degenerative

Eligibility Criteria

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

Inclusion Criteria:

  • Severe functional or degenerative TR
  • Symptomatic despite medical therapy
  • The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair

Exclusion Criteria:

  • Unsuitable anatomy
  • Previous tricuspid valve repair or replacement
  • Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Sites / Locations

  • Cedars Sinai Medical Center
  • Emory University Hospital
  • Northwestern University
  • St. Vincent Heart Center of Indiana
  • Henry Ford Hospital
  • Mayo Clinic
  • Morristown Medical Center
  • NYU Langone Health
  • Columbia University Medical Center/New York Presbyterian Hospital
  • Cleveland Clinic
  • Oregon Health & Science University
  • Lankenau Medical Center
  • The Heart Hospital Baylor Plano
  • Intermountain Medical Center
  • University of Virginia Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with the Edwards PASCAL Transcatheter Valve Repair System

Outcomes

Primary Outcome Measures

Freedom from device or procedure-related adverse events
Safety assessed by 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
November 13, 2018
Last Updated
March 27, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT03745313
Brief Title
Edwards CLASP TR EFS
Acronym
CLASP TR EFS
Official Title
Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 31, 2026 (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
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
Detailed Description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
Keywords
Functional, TR, FTR, Transcatheter, Repair, Regurgitation, Degenerative

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with the Edwards PASCAL Transcatheter Valve Repair System
Intervention Type
Device
Intervention Name(s)
Edwards PASCAL Transcatheter Valve Repair System
Intervention Description
Repair of the tricuspid valve through a transcatheter approach
Primary Outcome Measure Information:
Title
Freedom from device or procedure-related adverse events
Description
Safety assessed by 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, 1 year
Title
Reduction in TR grade
Description
Number of patients with reduction in TR from baseline
Time Frame
30 days, 3 Months ,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, 1 year
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, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe functional or degenerative TR Symptomatic despite medical therapy The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair Exclusion Criteria: Unsuitable anatomy Previous tricuspid valve repair or replacement Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susheel K. 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
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33509390
Citation
Kodali S, Hahn RT, Eleid MF, Kipperman R, Smith R, Lim DS, Gray WA, Narang A, Pislaru SV, Koulogiannis K, Grayburn P, Fowler D, Hawthorne K, Dahou A, Deo SH, Vandrangi P, Deuschl F, Mack MJ, Leon MB, Feldman T, Davidson CJ; CLASP TR EFS Investigators. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Feb 2;77(4):345-356. doi: 10.1016/j.jacc.2020.11.047.
Results Reference
derived

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Edwards CLASP TR EFS

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