PASCAL for Tricuspid Regurgitation - a European Registry

• Conditions: Tricuspid Regurgitation

• Registration Number: NCT05328284
• Lead Sponsor: LMU Klinikum

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.

Study Timeline

• Study Start: 2021-05-05
• Study First Submitted: 2022-03-15
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-06
• Last Update Submitted: 2022-04-06
• Study First Posted: 2022-04-14
• Last Update Posted: 2022-04-14
• Primary Completion: 2023-05-30
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• Patient age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of TR severity	1 year	TR ≤ grade 2+ (moderate)

Secondary Outcome Measures

Name	Time	Method
6-minute walk distance (6MWD)	1 year	physical capacity measured by 6MWD in meters
Rate of procedural safety	1 week	Absence of periprocedural and in-hospital adverse events
pulmonary artery pressure (PAP)	1 year	estimated PAP by echocardiography (in mmHg)
Rate of technical success	1 day	absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery
transtricuspid gradient	1 year	transvalvular antegrade gradient over tricuspid valve (in mmHg)
NT-proBNP level	last available follow-up (at least 1 year after intervention)	cardiac biomarker level (in pg/nl)
tricuspid regurgitation severity	last available follow-up (at least 1 year after intervention)	TR severity grading on a five-grade scheme (1-5)
right heart function	1 year	tricuspid annular plane systolic excursion (TAPSE, in mm)
right heart dimension	1 year	Right ventricular end-diastolic Diameter (in mm)
New York Heart Association (NYHA) functional class	1 year	Level of exertional dyspnea (I - IV)
inferior vena cava (IVC) dimension	1 year	IVC Diameter during expiration (in mm)

Trial Locations

Locations (14)

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Herz & Diabeteszentrum Nordrhein Westfalen; 🇩🇪 Bad Oeynhausen, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Marienkrankenhaus Hamburg; 🇩🇪 Hamburg, Germany

Universitäres Herz- und Gefäßzentrum Hamburg; 🇩🇪 Hamburg, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

LMU University Hospital; 🇩🇪 Munich, Germany

Universitätsklinikum Siegburg; 🇩🇪 Siegburg, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tuebingen, Germany

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