NCT05328284

Brief Summary

This study aims to investigate the safety and efficacy of the PASCAL leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating Centers in an observational fashion.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
3 countries

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

March 15, 2022

Last Update Submit

April 6, 2022

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Change of TR severity

    TR ≤ grade 2+ (moderate)

    1 year

Secondary Outcomes (11)

  • Rate of technical success

    1 day

  • Rate of procedural safety

    1 week

  • New York Heart Association (NYHA) functional class

    1 year

  • 6-minute walk distance (6MWD)

    1 year

  • NT-proBNP level

    last available follow-up (at least 1 year after intervention)

  • +6 more secondary outcomes

Study Arms (1)

PASCAL

patients treated with PASCAL leaflet repair system in the treatment of TR in a commercial use setting

Device: PASCAL leaflet repair system

Interventions

PASCAL leaflet repair systemDEVICE

transcatheter Implantation of one or more PASCAL devices in the tricuspid valve

PASCAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All consecutive patients that have undergone transcatheter tricuspid valve repair with the PASCAL system since its commercial approval in 02/2019 at the participating centres shall be included in the study.

You may qualify if:

  • Patients treated with the PASCAL system for tricuspid regurgitation in a commercial setting

You may not qualify if:

  • Patient age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

RECRUITING

Herz & Diabeteszentrum Nordrhein Westfalen

Bad Oeynhausen, Germany

RECRUITING

Universitätsklinikum Essen

Essen, Germany

RECRUITING

Marienkrankenhaus Hamburg

Hamburg, Germany

RECRUITING

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, Germany

NOT YET RECRUITING

Herzzentrum Leipzig

Leipzig, Germany

RECRUITING

LMU University Hospital

Munich, Germany

RECRUITING

Universitätsklinikum Siegburg

Siegburg, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Germany

RECRUITING

Universitätsklinik Ulm

Ulm, Germany

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Inselspital Bern

Bern, Switzerland

RECRUITING

Kantonsspital Luzern LUKS

Lucerne, Switzerland

RECRUITING

Related Publications (1)

  • Wild MG, Stolz L, Rosch S, Rudolph F, Goebel B, Koll B, von Stein P, Rottbauer W, Rassaf T, Beucher H, Kraus M, Kassar M, Geisler T, Ruck A, Ferreira-Martins J, Toggweiler S, Sagmeister P, Westermann D, Stocker TJ, Weckbach LT, Nabauer M, Settergren M, Dawkins S, Kister T, Praz F, Vorpahl M, Konstandin MH, Ludike P, Kessler M, Iliadis C, Kalbacher D, Lauten P, Gercek M, Besler C, Lurz P, Hausleiter J; PASTE Investigators. Transcatheter Valve Repair for Tricuspid Regurgitation: 1-Year Results From a Large European Real-World Registry. J Am Coll Cardiol. 2025 Jan 28;85(3):220-231. doi: 10.1016/j.jacc.2024.10.068. Epub 2024 Oct 28.

    PMID: 39466215DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Jörg Hausleiter, MD

CONTACT

+49 89 4400 72360joerg.hausleiter@med.uni-muenchen.de

Mirjam Wild, MD

CONTACT

mirjam.wild@med.uni-muenchen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 14, 2022

Study Start

May 5, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2024

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)DE(11)SE(1)