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NCT Number: NCT04443218

Edwards PASCAL Transcatheter Valve Repair System Registry

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.

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Key information

Conditions

Mitral Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMU Klinikum der Universität München, München, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Edwards PASCAL Transcatheter Valve Repair System

Device

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

Primary outcomes

  1. Major Adverse Events (MAEs)

    Time frame: 30 days

    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)

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

    Time frame: 30 days, 12 months

    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+).

Secondary outcomes

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

    Time frame: Baseline, 30 days, 12 months

    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).

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

    Time frame: Baseline, 30 days, 12 months

    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).

  3. New York Heart Association (NYHA) Functional Classification

    Time frame: Baseline, 30 days, 12 months

    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.

  4. 6-Minute Walk Test (6MWT)

    Time frame: Baseline, 30 days, 12 months

    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.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Acronym: PASCALRegistry

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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