Clinical trial NCT05328284: PASCAL for Tricuspid Regurgitation - a European Registry
Official title: PASTE: PASCAL for Tricuspid Regurgitation - a European Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tricuspid Regurgitation
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients that have undergone transcatheter tricuspid valve repair with the PASCAL system since its commercial approval in 02/2019 at the participating centres shall be included in the study.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patient age \< 18 years

Primary outcomes:
measure: Change of TR severity
timeFrame: 1 year
Secondary outcomes:
measure: Rate of technical success
timeFrame: 1 day
measure: Rate of procedural safety
timeFrame: 1 week
measure: New York Heart Association (NYHA) functional class
timeFrame: 1 year
measure: 6-minute walk distance (6MWD)
timeFrame: 1 year
measure: NT-proBNP level
timeFrame: last available follow-up (at least 1 year after intervention)
measure: right heart dimension
timeFrame: 1 year
measure: right heart function
timeFrame: 1 year
measure: tricuspid regurgitation severity
timeFrame: last available follow-up (at least 1 year after intervention)
measure: transtricuspid gradient
timeFrame: 1 year
measure: pulmonary artery pressure (PAP)
timeFrame: 1 year
measure: inferior vena cava (IVC) dimension
timeFrame: 1 year
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Oeynhausen
country: Germany
facility: Herz & Diabeteszentrum Nordrhein Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: Marienkrankenhaus Hamburg
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum Hamburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Munich
country: Germany
facility: LMU University Hospital
city: Siegburg
country: Germany
facility: Universitätsklinikum Siegburg
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinik Ulm
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern LUKS
Study officials:
References: