Edwards PASCAL Transcatheter Valve Repair System Registry

Edwards Lifesciences220 enrolled

Overview

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.

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

220

Conditions

Mitral Valve Insufficiency

Interventions

Edwards PASCAL Transcatheter Valve Repair SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

LMU Klinikum der Universität München

München, Bavaria, Germany

Immanuel Klinikum Bernau

Bernau bei Berlin, Brandenburg, Germany

Universitätsklinikum Gießen

Outcomes

Primary Outcomes

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)

Time frame: 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+).

Time frame: 30 days, 12 months

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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