PASCAL for Tricuspid Regurgitation - a European Registry

Tricuspid Regurgitation Clinical Trial

— PASTE  

Official title:

PASTE: PASCAL for Tricuspid Regurgitation - a European Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328284
• Other study ID #: 21-0385
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2022
• Source: LMU Klinikum
• Contact: Jörg Hausleiter, MD
• Phone: +49 89 4400 72360
• Email: joerg.hausleiter[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient age < 18 years

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• PASCAL leaflet repair system
transcatheter Implantation of one or more PASCAL devices in the tricuspid valve

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Herz & Diabeteszentrum Nordrhein Westfalen	Bad Oeynhausen
Germany	Universitätsklinikum Essen	Essen
Germany	Marienkrankenhaus Hamburg	Hamburg
Germany	Universita¨res Herz- und Gefa¨ßzentrum Hamburg	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Herzzentrum Leipzig	Leipzig
Germany	LMU University Hospital	Munich
Germany	Universitätsklinikum Siegburg	Siegburg
Germany	Universitätsklinikum Tübingen	Tuebingen
Germany	Universitätsklinik Ulm	Ulm
Sweden	Karolinska University Hospital	Stockholm
Switzerland	Inselspital Bern	Bern
Switzerland	Kantonsspital Luzern LUKS	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
LMU Klinikum

Countries where clinical trial is conducted

Germany,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of TR severity	TR = grade 2+ (moderate)	1 year
Secondary	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
Secondary	Rate of procedural safety	Absence of periprocedural and in-hospital adverse events	1 week
Secondary	New York Heart Association (NYHA) functional class	Level of exertional dyspnea (I - IV)	1 year
Secondary	6-minute walk distance (6MWD)	physical capacity measured by 6MWD in meters	1 year
Secondary	NT-proBNP level	cardiac biomarker level (in pg/nl)	last available follow-up (at least 1 year after intervention)
Secondary	right heart dimension	Right ventricular end-diastolic Diameter (in mm)	1 year
Secondary	right heart function	tricuspid annular plane systolic excursion (TAPSE, in mm)	1 year
Secondary	tricuspid regurgitation severity	TR severity grading on a five-grade scheme (1-5)	last available follow-up (at least 1 year after intervention)
Secondary	transtricuspid gradient	transvalvular antegrade gradient over tricuspid valve (in mmHg)	1 year
Secondary	pulmonary artery pressure (PAP)	estimated PAP by echocardiography (in mmHg)	1 year
Secondary	inferior vena cava (IVC) dimension	IVC Diameter during expiration (in mm)	1 year