Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

Active, not recruiting

• Conditions: Tricuspid Valve Insufficiency

• Registration Number: NCT04614402
• Lead Sponsor: Edwards Lifesciences

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.

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 Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-11-04
• Study Start: 2021-01-15
• Primary Completion: 2023-04-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Study Completion: 2028-03-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography	Discharge: defined as discharge or 7 days post-procedure, whichever comes first	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.
Number of patients with major adverse events (MAE rates)	30 days	The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days

Secondary Outcome Measures

Name	Time	Method
Functional class, functional status, and Quality of life as assessed	baseline, 30 days, 6 months, 12 months, annually up to 5 years	Kansas City Cardiomyopathy Questionnaire
Volume overload assessed by serial measurements	baseline, 30 days, 6 months, 12 months, annually up to 5 years	Ankle circumference measurement in cm

Trial Locations

Locations (15)

Hygeia Hospital; 🇬🇷 Athens, Greece

Ospedale del Cuore "G. Pasquinucci"; 🇮🇹 Massa, Italy

Heart Centre of the University Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Kath. Marienkrankenhaus Hamburg gGmbH; 🇩🇪 Hamburg, Germany

University Heart Center Lübeck; 🇩🇪 Lübeck, Germany

Universitätsklinikum Ulm Innere Medizin II; 🇩🇪 Ulm, Baden-Wuerttemberg, Germany

Herzzentrum Universitätsklinikum Köln; 🇩🇪 Köln, DEU, Germany

Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie; 🇩🇪 Essen, Nordrhine Westfalia, Germany

Herz- und Diabeteszentrum NRW - Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, North Rhine Westphalia, Germany

Herzzentrum der Universitätsklinik Bonn; 🇩🇪 Bonn, North Rhine Westphalia, Germany

UKE Hamburg; 🇩🇪 Hamburg, Germany

Inselspital; 🇨🇭 Bern, Switzerland

Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie; 🇩🇪 Tübingen, Baden-Württemberg, Germany

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Thuringia, Germany

Medizinische Klinik I- Campus Grosshadern; 🇩🇪 München, Bavaria, Germany