Clinical trial NCT03745313: Edwards CLASP TR EFS
Official title: Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: Functional
TR
FTR
Transcatheter
Repair
Regurgitation
Degenerative
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-11-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Composite Major Adverse Event (MAE) Rate
timeFrame: 30 days
Secondary outcomes:
measure: Device Success
timeFrame: Intraprocedural
measure: Procedural Success
timeFrame: Discharge (2-7 days)
measure: Clinical Success
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: Columbia University
name: Susheel K. Kodali, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.