Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population
LEAFLET I
Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population
1 other identifier
interventional
180
1 country
1
Brief Summary
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
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
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 26, 2024
CompletedFirst Posted
Study publicly available on registry
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
October 9, 2024
October 1, 2024
3 years
August 26, 2024
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postprocedural residual MR measured by 3D EROA
residual MR measured by 3D EROA as continuous parameter
During the index procedure
Secondary Outcomes (10)
Reduction in MR EROA
During the index procedure
Comparing EROA in complex vs. non-complex patients
During the index procedure
Postprocedural MV opening area
During the index procedure
Postprocedural MV inflow gradient
During the index procedure
SLDA
During the index procedure, at 30-day follow-up and at 1-year follow-up
- +5 more secondary outcomes
Study Arms (2)
MitraClip
ACTIVE COMPARATORPASCAL
ACTIVE COMPARATORInterventions
M-TEER is performed via a transfemoral venous approach. After puncture of the interatrial septum the mitral valve is repaired using either the PASCAL or MitraClip device.
Eligibility Criteria
You may qualify if:
- Age equal or above 18 years
- Written consent
- Heart Team recommends M-TEER
You may not qualify if:
- Mitral Stenosis (MV mean PG \> 5 mmHg)
- Cardiogenic shock or hemodynamic instability at the time of intervention
- Active endocarditis
- Participant in another interventional cardiology study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LMU Klinikumlead
Study Sites (1)
LMU Klinikum
Munich, Bavaria, 81377, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jörg Hausleiter, Prof. Dr.
LMU Klinikum
- PRINCIPAL INVESTIGATOR
Ludwig Weckbach, PD Dr.
LMU Klinikum
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy chief
Study Record Dates
First Submitted
August 26, 2024
First Posted
October 9, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
October 9, 2024
Record last verified: 2024-10