PASCAL for Tricuspid Regurgitation - a European Registry (PASTE)

L

LMU Klinikum

Status

Enrolling

Conditions

Tricuspid Regurgitation

Treatments

Device: PASCAL leaflet repair system

Study type

Observational

Funder types

Other

Identifiers

NCT05328284
21-0385

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Patient age < 18 years

Trial design

1,000 participants in 1 patient group

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

Trial contacts and locations

14

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Central trial contact

Jörg Hausleiter, MD; Mirjam Wild, MD

Data sourced from clinicaltrials.gov

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