Clinical trial NCT04614402: Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
Official title: Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tricuspid Valve Insufficiency
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with major adverse events (MAE rates)
timeFrame: 30 days
measure: Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
timeFrame: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Secondary outcomes:
measure: Volume overload assessed by serial measurements
timeFrame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
measure: Volume overload assessed by serial measurements
timeFrame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
measure: Volume overload assessed by serial measurements
timeFrame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
measure: Volume overload assessed by serial measurements
timeFrame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
measure: Functional class, functional status, and Quality of life as assessed
timeFrame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
measure: Functional class, functional status, and Quality of life as assessed
timeFrame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
measure: Functional class, functional status, and Quality of life as assessed
timeFrame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
measure: Functional class, functional status, and Quality of life as assessed
timeFrame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm Innere Medizin II
state: Baden-Wuerttemberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie
state: Baden-Württemberg
city: München
country: Germany
facility: Medizinische Klinik I- Campus Grosshadern
state: Bavaria
city: Köln
country: Germany
facility: Herzzentrum Universitätsklinikum Köln
state: DEU
city: Essen
country: Germany
facility: Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie
state: Nordrhine Westfalia
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen
state: North Rhine Westphalia
city: Bonn
country: Germany
facility: Herzzentrum der Universitätsklinik Bonn
state: North Rhine Westphalia
city: Leipzig
country: Germany
facility: Heart Centre of the University Leipzig
state: Saxony
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
state: Thuringia
city: Hamburg
country: Germany
facility: UKE Hamburg
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus Hamburg gGmbH
city: Lübeck
country: Germany
facility: University Heart Center Lübeck
city: Athens
country: Greece
facility: Hygeia Hospital
city: Massa
country: Italy
facility: Ospedale del Cuore "G. Pasquinucci"
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin
name: Stephan Baldus, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.