Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System (TriCLASP)

Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tricuspid Valve Insufficiency
• Intervention / Treatment: Device: Edwards PASCAL Transcatheter Valve Repair System; Device: Edwards PASCAL Precision Transcatheter Valve Repair System

Detailed Description

The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: TMTT Clinical Affairs; Phone Number: 2500 +1 (949) 250; Email: TMTT_Clinical@edwards.com

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • UKE Hamburg
  • Hamburg, Germany, 22087
    • Kath. Marienkrankenhaus Hamburg gGmbH
  • Lübeck, Germany
    • University Heart Center Lübeck
  • Baden-Wuerttemberg
    • Ulm, Baden-Wuerttemberg, Germany, 89070
      • Universitätsklinikum Ulm Innere Medizin II
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie
  • Bavaria
    • München, Bavaria, Germany, 81377
      • Medizinische Klinik I- Campus Grosshadern
  • DEU
    • Köln, DEU, Germany, D-50937
      • Herzzentrum Universitätsklinikum Köln
  • Nordrhine Westfalia
    • Essen, Nordrhine Westfalia, Germany, 45147
      • Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie
  • North Rhine Westphalia
    • Bad Oeynhausen, North Rhine Westphalia, Germany, 32545
      • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
    • Bonn, North Rhine Westphalia, Germany, 53127
      • Herzzentrum der Universitätsklinik Bonn
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Heart Centre of the University Leipzig
  • Thuringia
    • Bad Berka, Thuringia, Germany, 99437
      • Zentralklinik Bad Berka GmbH
• Greece
  • Athens, Greece, 151 23
    • Hygeia Hospital
• Italy
  • Massa, Italy
    • Ospedale del Cuore "G. Pasquinucci"
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team
2. TR grade ≥3+ (5 grade classification)
3. Patient is eligible to receive the PASCAL device per the current approved indications for use

Exclusion Criteria:

1. Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement
2. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
3. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
4. Any patient considered to be part of a vulnerable population

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume overload assessed by serial measurements	Patient edema questionnaire	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements	Body weight in kilogram	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements	Edema Assessment (scale 1+ - 4+) grade correspond to mm	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements	Ankle circumference measurement in cm	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed	NYHA classification (I-IV) grade	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed	6-Minute Walk Test in meter	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed	5 Level EQ 5D Questionnaire	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed	Kansas City Cardiomyopathy Questionnaire	baseline, 30 days, 6 months, 12 months, annually up to 5 years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Stephan Baldus, Prof. Dr., Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin

Publications and helpful links

General Publications

• Baldus S, Schofer N, Hausleiter J, Friedrichs K, Lurz P, Luedike P, Frerker C, Nickenig G, Lubos E, Pfister R, Korber MI, Kalbacher D, Nabauer M, Besler C, Mahabadi AA, Weber M, Zdanyte M, Ren CB, Geisler T. Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results. Catheter Cardiovasc Interv. 2022 Dec;100(7):1291-1299. doi: 10.1002/ccd.30450. Epub 2022 Nov 15.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): April 20, 2023
• Study Completion (Estimated): March 15, 2028

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 2019-11 (APHM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes