PASCAL for Tricuspid Regurgitation - a European Registry

NCT ID: NCT05328284

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2024-05-30

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.

Detailed Description

Tricuspid regurgitation (TR) is associated with high morbidity and mortality, but many patients are ineligible for surgical treatment due to age and co-morbidities. As a consequence, transcatheter treatment techniques have evolved over the last years. Leaflet repair is one of the most commonly used techniques and has recently gained commercial approval for dedicated TR treatment. The PASCAL (Edwards Lifesciences, Irvine, USA) offers the possibility for independent leaflet grasping and a central spacer can bridge larger coaptation gaps. The hitherto evidence is mainly based on compassionate use data. This study aims to report the first commercial use in a multicenter study with a large patient cohort und long-term follow-up.

Aim of the study is to investigate safety and efficacy of the PASCAL leaflet repair system in the treatment of TR in a commercial use setting.

Study design is a multicenter, single-device, retro- and prospective, observational registry. All consecutive patients undergoing treatment with the PASCAL system for tricuspid regurgitation in a commercial setting are included.

Conditions

Tricuspid Regurgitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PASCAL

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

PASCAL leaflet repair system

Intervention Type: DEVICE

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

Interventions

PASCAL leaflet repair system

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patient age < 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LMU Klinikum

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Jörg Hausleiter

Deputy chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Site Status: RECRUITING

Herz & Diabeteszentrum Nordrhein Westfalen

Bad Oeynhausen, , Germany

Site Status: RECRUITING

Universitätsklinikum Essen

Essen, , Germany

Site Status: RECRUITING

Marienkrankenhaus Hamburg

Hamburg, , Germany

Site Status: RECRUITING

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, , Germany

Site Status: RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status: NOT_YET_RECRUITING

Herzzentrum Leipzig

Leipzig, , Germany

Site Status: RECRUITING

LMU University Hospital

Munich, , Germany

Site Status: RECRUITING

Universitätsklinikum Siegburg

Siegburg, , Germany

Site Status: RECRUITING

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status: RECRUITING

Universitätsklinik Ulm

Ulm, , Germany

Site Status: RECRUITING

Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Inselspital Bern

Bern, , Switzerland

Site Status: RECRUITING

Kantonsspital Luzern LUKS

Lucerne, , Switzerland

Site Status: RECRUITING

Countries

Germany; Sweden; Switzerland

Central Contacts

Jörg Hausleiter, MD

Role: CONTACT

joerg.hausleiter@med.uni-muenchen.de

+49 89 4400 72360

Mirjam Wild, MD

Role: CONTACT

mirjam.wild@med.uni-muenchen.de

Facility Contacts

Harald Lapp, MD

Role: primary

Harald.Lapp@zentralklinik.de

Volker Rudolph, MD

Role: primary

vrudolph@hdz-nrw.de

Peter Lüdike, MD

Role: primary

Peter.Luedike@uk-essen.de

Edith Lubos

Role: primary

e.lubos@marienkrankenhaus.org

Niklas Schofer, MD

Role: primary

n.schofer@uke.de

Mathias Konstandin

Role: primary

Mathias.Konstandin@med.uni-heidelberg.de

Philipp Lurz, MD

Role: primary

Philipp.Lurz@medizin.uni-leipzig.de

Jörg Hausleiter, MD

Role: primary

joerg.hausleiter@med.uni-muenchen.de

Peter Boekstegers, MD

Role: primary

Tobias Geisler

Role: primary

Tobias.Geisler@med.uni-tuebingen.de

Mirjam Kessler, MD

Role: primary

mirjam.kessler@uniklinik-ulm.de

Andreas Rück, MD, PhD

Role: primary

andreas.ruck@regionstockholm.se

Fabien Praz, MD

Role: primary

fabien.praz@insel.ch

Stefan Toggweiler, MD

Role: primary

stefan.toggweiler@luks.ch

References

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.

Reference Type: DERIVED

PMID: 39466215 (View on PubMed)

Other Identifiers

21-0385

Identifier Type: -

Identifier Source: org_study_id