Edwards PASCAL Transcatheter Valve Repair System Registry

Mitral Valve Insufficiency Clinical Trial

— PASCALRegistry  

Official title:

Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04443218
• Other study ID #: 2019-03
• Status: Active, not recruiting
• Start date: May 27, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post Market Clinical Follow-up (PMCF) study.

Description:

Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient signs informed consent to participate in the registry

• Patient is intended to or has received the PASCAL device

Exclusion Criteria:

• Patient does not consent to participate

• Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• Edwards PASCAL Transcatheter Valve Repair System
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW - Bad Oeynhausen	Bad Oeynhausen	North Rhine Westphalia
Germany	Immanuel Klinikum Bernau	Bernau	Brandenburg
Germany	Herzzentrum der Universitätsklinik Bonn	Bonn	North Rhine Westphalia
Germany	Herzzentrum Köln	Cologne	Nord Rhine Westphalia
Germany	St.-Johannes-Hospital Dortmund	Dortmund	North Rhine Westphalia
Germany	Herzzentrum Universitätsklinik Dresden	Dresden	Saxony
Germany	Elisabeth-Krankenhaus Essen	Essen	North Rhine Westphalia
Germany	Universitätsklinikum Gießen	Gießen	Hesse
Germany	Georg-August-Universität Göttingen, Universitätsmedizin Göttingen	Göttingen	Lower Saxony
Germany	Kath. Marienkrankenhaus Hamburg GmbH	Hamburg
Germany	Heart Centre of the University Leipzig	Leipzig	Saxony
Germany	Universitätsmedizin der Johannes Gutenberg Universität Mainz	Mainz	Rhineland-Palatinate
Germany	LMU Klinikum der Universität München	München	Bavaria
Switzerland	Inselspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events (MAEs)	Rates of Major Adverse Events (MAE) at 30 days.	30 days
Primary	Mitral Regurgitation Change	Change in severity of mitral regurgitation	30 days
Primary	Mitral Regurgitation Change	Change in severity of mitral regurgitation	12 months
Secondary	Change in Quality of Life - KCCQ	Change in Quality of Life as assessed by KCCQ	30 days
Secondary	Change in Quality of Life - KCCQ	Change in Quality of Life as assessed by KCCQ	12 months
Secondary	Change in Quality of Life - EuroQol Group EQ-5D	Change in Quality of Life as assessed by EuroQol Group EQ-5D	30 days
Secondary	Change in Quality of Life - EuroQol Group EQ-5D	CHange in Quality of Life as assessed by EuroQol Group EQ-5D	12 months
Secondary	New York Heart Association scale	Change in NYHA scale rated from I-IV	30 days
Secondary	New York Heart Association scale	Change in NYHA scale rated from I-IV	12 months
Secondary	6 Minute Walk test	Change in distance in meters in the 6 minute walk test	30 days
Secondary	6 Minute Walk test	Change in distance in meters in the 6 minute walk test	12 months