NCT05328284

PASCAL for Tricuspid Regurgitation - a European Registry

PASTE: PASCAL for Tricuspid Regurgitation - a European Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	PASCAL leaflet repair system	transcatheter Implantation of one or more PASCAL devices in the tricuspid valve

Timeline

• Start date: 2021-05-05
• Primary completion: 2023-05-30
• Completion: 2024-05-30
• First posted: 2022-04-14
• Last updated: 2022-04-14

Locations

14 sites across 3 countries: Germany, Sweden, Switzerland