PASCAL for Tricuspid Regurgitation - a European Registry (PASTE)

PASTE: PASCAL for Tricuspid Regurgitation - a European Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: PASCAL leaflet repair system

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jörg Hausleiter, MD; Phone Number: +49 89 4400 72360; Email: joerg.hausleiter@med.uni-muenchen.de
• Study Contact Backup: Name: Mirjam Wild, MD; Email: mirjam.wild@med.uni-muenchen.de

Study Locations

• Germany
  • Bad Berka, Germany
    • Recruiting
    • Zentralklinik Bad Berka GmbH
    • Contact: Harald Lapp, MD; Email: Harald.Lapp@zentralklinik.de
  • Bad Oeynhausen, Germany
    • Recruiting
    • Herz & Diabeteszentrum Nordrhein Westfalen
    • Contact: Volker Rudolph, MD; Email: vrudolph@hdz-nrw.de
  • Essen, Germany
    • Recruiting
    • Universitatsklinikum Essen
    • Contact: Peter Lüdike, MD; Email: Peter.Luedike@uk-essen.de
  • Hamburg, Germany
    • Recruiting
    • Universitäres Herz- und Gefäßzentrum Hamburg
    • Contact: Niklas Schofer, MD; Email: n.schofer@uke.de
  • Hamburg, Germany
    • Recruiting
    • Marienkrankenhaus Hamburg
    • Contact: Edith Lubos; Email: e.lubos@marienkrankenhaus.org
  • Heidelberg, Germany
    • Not yet recruiting
    • UniversitatsKlinikum Heidelberg
    • Contact: Mathias Konstandin; Email: Mathias.Konstandin@med.uni-heidelberg.de
  • Leipzig, Germany
    • Recruiting
    • Herzzentrum Leipzig
    • Contact: Philipp Lurz, MD; Email: Philipp.Lurz@medizin.uni-leipzig.de
  • Munich, Germany
    • Recruiting
    • LMU University Hospital
    • Contact: Jörg Hausleiter, MD; Email: joerg.hausleiter@med.uni-muenchen.de
  • Siegburg, Germany
    • Recruiting
    • Universitätsklinikum Siegburg
    • Contact: Peter Boekstegers, MD
  • Tuebingen, Germany
    • Recruiting
    • Universitatsklinikum Tubingen
    • Contact: Tobias Geisler; Email: Tobias.Geisler@med.uni-tuebingen.de
  • Ulm, Germany
    • Recruiting
    • Universitätsklinik Ulm
    • Contact: Mirjam Kessler, MD; Email: mirjam.kessler@uniklinik-ulm.de
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Andreas Rück, MD, PhD; Email: andreas.ruck@regionstockholm.se
• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Inselspital Bern
    • Contact: Fabien Praz, MD; Email: fabien.praz@insel.ch
  • Luzern, Switzerland
    • Recruiting
    • Kantonsspital Luzern LUKS
    • Contact: Stefan Toggweiler, MD; Email: stefan.toggweiler@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient age < 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PASCAL; patients treated with PASCAL leaflet repair system in the treatment of TR in a commercial use setting	Device: PASCAL leaflet repair system; transcatheter Implantation of one or more PASCAL devices in the tricuspid valve

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LMU Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 21-0385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No