Edwards PASCAL Transcatheter Valve Repair System Registry

NCT04443218 | Completed Results

• 1 other identifier: 2019-03
• Study Type: observational
• Target: 220
• Locations: 2 countries
• Sites: 14

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.

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (2)

• Major Adverse Events (MAEs)

  Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair \[TEER\] or mitral valve surgery)

  30 days

• Mitral Regurgitation (MR) Reduction to <=2+

  MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+).

  30 days, 12 months

Secondary Outcomes (4)

• Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores

  Baseline, 30 days, 12 months

• Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)

  Baseline, 30 days, 12 months

• New York Heart Association (NYHA) Functional Classification

  Baseline, 30 days, 12 months

• 6-Minute Walk Test (6MWT)

  Baseline, 30 days, 12 months

Interventions

Edwards PASCAL Transcatheter Valve Repair System DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Mitral Regurgitation eligible to receive the PASCAL device

You may qualify if:

• Patient signs informed consent to participate in the registry
• Patient is intended to or has received the PASCAL device

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (14)

LMU Klinikum der Universität München

München, Bavaria, 81377, Germany

Location

Immanuel Klinikum Bernau

Bernau bei Berlin, Brandenburg, 16321, Germany

Location

Universitätsklinikum Gießen

Giessen, Hesse, 35392, Germany

Location

Georg-August-Universität Göttingen, Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Herzzentrum Köln

Cologne, Nord Rhine Westphalia, 50937, Germany

Location

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Herzzentrum der Universitätsklinik Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

St.-Johannes-Hospital Dortmund

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, North Rhine-Westphalia, 45138, Germany

Location

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Herzzentrum Universitätsklinik Dresden

Dresden, Saxony, 01307, Germany

Location

Heart Centre of the University Leipzig

Leipzig, Saxony, 04289, Germany

Location

Kath. Marienkrankenhaus Hamburg GmbH

Hamburg, 22087, Germany

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Interpretation of some outcome measures is limited by significant incomplete and/or missing data due to retrospective data collection, differences in data collected as part of standard of care across sites, and use of alternative follow-up data collection methods in lieu of in-person clinical visits. Additionally, this registry did not use an echocardiography core laboratory to assess echocardiography parameters or a clinical events committee to adjudicate adverse events.

Results Point of Contact

• Title: Ted Feldman
• Organization: Edwards Lifesciences

Feldman_Info@edwards.com

949-250-2500

Study Officials

• Joerg Hausleiter, Prof.

  MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: June 23, 2020
• Study Start: May 27, 2019
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-02

Locations

CH (1); DE (13)