Edwards PASCAL Transcatheter Valve Repair System Registry

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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 Outcome Measures

Name	Time	Method
Major Adverse Events (MAEs)	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)
Mitral Regurgitation (MR) Reduction to <=2+	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 Outcome Measures

Name	Time	Method
6-Minute Walk Test (6MWT)	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.
New York Heart Association (NYHA) Functional Classification	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.
Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores	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).
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)	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).

Locations (14): Kath. Marienkrankenhaus Hamburg GmbH
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Hamburg, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
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Bad Oeynhausen, North Rhine Westphalia, Germany
Herzzentrum Köln
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Cologne, Nord Rhine Westphalia, Germany
Herzzentrum der Universitätsklinik Bonn
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Bonn, North Rhine Westphalia, Germany
Elisabeth-Krankenhaus Essen
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Essen, North Rhine Westphalia, Germany
St.-Johannes-Hospital Dortmund
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Dortmund, North Rhine Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
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Mainz, Rhineland-Palatinate, Germany
Herzzentrum Universitätsklinik Dresden
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Dresden, Saxony, Germany
Inselspital Bern
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Bern, Switzerland
Universitätsklinikum Gießen
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Gießen, Hesse, Germany
Georg-August-Universität Göttingen, Universitätsmedizin Göttingen
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Göttingen, Lower Saxony, Germany
LMU Klinikum der Universität München
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München, Bavaria, Germany
Immanuel Klinikum Bernau
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Bernau, Brandenburg, Germany
Heart Centre of the University Leipzig
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Leipzig, Saxony, Germany