PASCAL for Tricuspid Regurgitation - a European Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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PASTE: PASCAL for Tricuspid Regurgitation - a European Registry

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Device: PASCAL leaflet repair system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with the PASCAL system for tricuspid regurgitation in a commercial setting Exclusion Criteria: Patient age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PASCAL<br>patients treated with PASCAL leaflet repair system in the treatment of TR in a commercial use setting | Device: PASCAL leaflet repair system<br>* transcatheter Implantation of one or more PASCAL devices in the tricuspid valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of TR severity | TR ≤ grade 2+ (moderate) | 1 year | 

Secondary Outcome Measures

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