Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
TriCLASP
1 other identifier
observational
300
4 countries
15
Brief Summary
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2028
ExpectedJuly 2, 2025
May 1, 2025
2.3 years
September 25, 2020
June 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients with major adverse events (MAE rates)
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
30 days
Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval.
Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Secondary Outcomes (8)
Volume overload assessed by serial measurements
baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed
baseline, 30 days, 6 months, 12 months, annually up to 5 years
- +3 more secondary outcomes
Interventions
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
Eligibility Criteria
Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient tricuspid valve (TR ≥ 3+) by a Heart Team who assesses patient risk and anatomic suitability for the procedure.
You may qualify if:
- Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team
- TR grade ≥3+ (5 grade classification)
- Patient is eligible to receive the PASCAL device per the current approved indications for use
You may not qualify if:
- Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement
- Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- Any patient considered to be part of a vulnerable population
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitätsklinikum Ulm Innere Medizin II
Ulm, Baden-Wurttemberg, 89070, Germany
Medizinische Klinik I- Campus Grosshadern
München, Bavaria, 81377, Germany
Herzzentrum Universitätsklinikum Köln
Cologne, DEU, D-50937, Germany
Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie
Essen, Nordrhine Westfalia, 45147, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Herzzentrum der Universitätsklinik Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Heart Centre of the University Leipzig
Leipzig, Saxony, 04289, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Thuringia, 99437, Germany
UKE Hamburg
Hamburg, 20246, Germany
Kath. Marienkrankenhaus Hamburg gGmbH
Hamburg, 22087, Germany
University Heart Center Lübeck
Lübeck, Germany
Hygeia Hospital
Athens, 151 23, Greece
Ospedale del Cuore "G. Pasquinucci"
Massa, Italy
Inselspital
Bern, 3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Baldus, Prof. Dr.
Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2020
First Posted
November 4, 2020
Study Start
January 15, 2021
Primary Completion
April 20, 2023
Study Completion (Estimated)
March 15, 2028
Last Updated
July 2, 2025
Record last verified: 2025-05