PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair
1 other identifier
observational
214
1 country
1
Brief Summary
Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedFirst Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedMay 19, 2023
May 1, 2023
3.3 years
May 8, 2023
May 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Procedural success
as defined by the Mitral Valve Academy Research Consortium (MVARC)
one month after implantation
Composite endpoint of all-cause death and heart failure hospitalization
one year after implantation
Secondary Outcomes (2)
Grade of Mitral Regurgitation
one month and one year after implantation
Functional status
one month and one year after implantation
Study Arms (2)
PASCAL-Group
M-TEER using MitraClip
MitraClip-Group
M-TEER using PASCAL
Interventions
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
Patients with severe symptomatic mitral regurgitation.
You may qualify if:
- Age ≥18 years
- 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
You may not qualify if:
- Life expectancy \< 1 year
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Malte Kelm, Prof.
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
- PRINCIPAL INVESTIGATOR
Patrick Horn, MD
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
- PRINCIPAL INVESTIGATOR
Jafer Haschemi, MD
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 19, 2023
Study Start
June 1, 2019
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
May 19, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share