PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair
NCT ID: NCT05865938
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
214 participants
OBSERVATIONAL
2019-06-01
2022-08-31
Brief Summary
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Detailed Description
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Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols.
This study is a subproject of the MitraClip® Registry (NCT02033811)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PASCAL-Group
M-TEER using MitraClip
PASCAL vs. MitraClip
transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR).
The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.
MitraClip-Group
M-TEER using PASCAL
PASCAL vs. MitraClip
transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR).
The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.
Interventions
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PASCAL vs. MitraClip
transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR).
The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.
Eligibility Criteria
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Inclusion Criteria
* Severe Mitral Regurgitation (3+ to 4+)
* Symptom status: NYHA functional class ≥ II
* Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high
Exclusion Criteria
* Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device
* Contraindication for transoesophageal echocardiography
* Active endocarditis
* Pregnant or planning pregnancy within next 12 months
18 Years
ALL
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Principal Investigators
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Malte Kelm, Prof.
Role: STUDY_CHAIR
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Patrick Horn, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Jafer Haschemi, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Locations
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Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, , Germany
Countries
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Other Identifiers
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PASCAL vs. MitralClip
Identifier Type: -
Identifier Source: org_study_id
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