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

Tricuspid Valve Insufficiency Clinical Trial

— TriCLASP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04614402
• Other study ID #: 2019-11
• Status: Active, not recruiting
• Start date: January 15, 2021
• Est. completion date: March 15, 2028

Study information

• Verified date: March 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: March 15, 2028
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

Device:
• Edwards PASCAL Transcatheter Valve Repair System
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
• Edwards PASCAL Precision Transcatheter Valve Repair System
The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka GmbH	Bad Berka	Thuringia
Germany	Herz- und Diabeteszentrum NRW - Bad Oeynhausen	Bad Oeynhausen	North Rhine Westphalia
Germany	Herzzentrum der Universitätsklinik Bonn	Bonn	North Rhine Westphalia
Germany	Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie	Essen	Nordrhine Westfalia
Germany	Kath. Marienkrankenhaus Hamburg gGmbH	Hamburg
Germany	UKE Hamburg	Hamburg
Germany	Herzzentrum Universitätsklinikum Köln	Köln	DEU
Germany	Heart Centre of the University Leipzig	Leipzig	Saxony
Germany	University Heart Center Lübeck	Lübeck
Germany	Medizinische Klinik I- Campus Grosshadern	München	Bavaria
Germany	Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie	Tübingen	Baden-Württemberg
Germany	Universitätsklinikum Ulm Innere Medizin II	Ulm	Baden-Wuerttemberg
Greece	Hygeia Hospital	Athens
Italy	Ospedale del Cuore "G. Pasquinucci"	Massa
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Germany,  Greece,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Volume overload assessed by serial measurements	Patient edema questionnaire	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Secondary	Volume overload assessed by serial measurements	Body weight in kilogram	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Secondary	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
Secondary	Volume overload assessed by serial measurements	Ankle circumference measurement in cm	baseline, 30 days, 6 months, 12 months, annually up to 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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