Edwards PASCAL Transcatheter Valve Repair System Registry (PASCALRegistry)

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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Insufficiency
• Intervention / Treatment: Device: Edwards PASCAL Transcatheter Valve Repair System

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.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22087
    • Kath. Marienkrankenhaus Hamburg GmbH
  • Bavaria
    • München, Bavaria, Germany, 81377
      • LMU Klinikum der Universität München
  • Brandenburg
    • Bernau, Brandenburg, Germany, 16321
      • Immanuel Klinikum Bernau
  • Hesse
    • Gießen, Hesse, Germany, 35392
      • Universitätsklinikum Gießen
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Georg-August-Universität Göttingen, Universitätsmedizin Göttingen
  • Nord Rhine Westphalia
    • Cologne, Nord Rhine Westphalia, Germany, 50937
      • Herzzentrum Köln
  • North Rhine Westphalia
    • Bad Oeynhausen, North Rhine Westphalia, Germany, 32545
      • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
    • Bonn, North Rhine Westphalia, Germany, 53127
      • Herzzentrum der Universitätsklinik Bonn
    • Dortmund, North Rhine Westphalia, Germany, 44137
      • St.-Johannes-Hospital Dortmund
    • Essen, North Rhine Westphalia, Germany, 45138
      • Elisabeth-Krankenhaus Essen
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Herzzentrum Universitätsklinik Dresden
    • Leipzig, Saxony, Germany, 04289
      • Heart Centre of the University Leipzig
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Mitral Regurgitation eligible to receive the PASCAL device

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores	KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life).	Baseline, 30 days, 12 months
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)	Patient's self-rated health on a visual analog scale (0-100 points; 0=worst health you can imagine and 100=best health you can imagine).	Baseline, 30 days, 12 months
New York Heart Association (NYHA) Functional Classification	NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity: Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.	Baseline, 30 days, 12 months
6-Minute Walk Test (6MWT)	6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.	Baseline, 30 days, 12 months

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Joerg Hausleiter, Prof., MD

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): May 10, 2021

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2019-03

Drug and device information, study documents

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