Clinical trial NCT04443218: Edwards PASCAL Transcatheter Valve Repair System Registry
Official title: Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Insufficiency
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2020-06-23
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Mitral Regurgitation eligible to receive the PASCAL device

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Events (MAEs)
timeFrame: 30 days
measure: Mitral Regurgitation (MR) Reduction to <=2+
timeFrame: 30 days, 12 months
Secondary outcomes:
measure: Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores
timeFrame: Baseline, 30 days, 12 months
measure: Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)
timeFrame: Baseline, 30 days, 12 months
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: Baseline, 30 days, 12 months
measure: 6-Minute Walk Test (6MWT)
timeFrame: Baseline, 30 days, 12 months
Other outcomes:
Locations:
city: München
country: Germany
facility: LMU Klinikum der Universität München
state: Bavaria
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau
state: Brandenburg
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
state: Hesse
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen, Universitätsmedizin Göttingen
state: Lower Saxony
city: Cologne
country: Germany
facility: Herzzentrum Köln
state: Nord Rhine Westphalia
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen
state: North Rhine Westphalia
city: Bonn
country: Germany
facility: Herzzentrum der Universitätsklinik Bonn
state: North Rhine Westphalia
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital Dortmund
state: North Rhine Westphalia
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
state: North Rhine Westphalia
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz
state: Rhineland-Palatinate
city: Dresden
country: Germany
facility: Herzzentrum Universitätsklinik Dresden
state: Saxony
city: Leipzig
country: Germany
facility: Heart Centre of the University Leipzig
state: Saxony
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus Hamburg GmbH
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: MD
name: Joerg Hausleiter, Prof.
role: PRINCIPAL_INVESTIGATOR
References: