Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation; Valvular Heart Disease; Heart Failure
• Interventions: Device: Transcatheter mitral valve edge-to-edge repair (M-TEER)

• Registration Number: NCT06634121
• Lead Sponsor: LMU Klinikum

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.

Detailed Description

In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-08-26
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Primary Completion: 2027-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Age equal or above 18 years
• Written consent
• Heart Team recommends M-TEER

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MitraClip	Transcatheter mitral valve edge-to-edge repair (M-TEER)	-
PASCAL	Transcatheter mitral valve edge-to-edge repair (M-TEER)	-

Primary Outcome Measures

Name	Time	Method
Postprocedural residual MR measured by 3D EROA	During the index procedure	residual MR measured by 3D EROA as continuous parameter

Secondary Outcome Measures

Name	Time	Method
Reduction in MR EROA	During the index procedure	Reduction in MR EROA from baseline to postprocedural (relative and absolut value)
Comparing EROA in complex vs. non-complex patients	During the index procedure	Evaluation according to EROA reduction
Postprocedural MV opening area	During the index procedure	Postprocedural MV opening area (planimetric)
Postprocedural MV inflow gradient	During the index procedure	Mean pressure gradient and pressure halftime
SLDA	During the index procedure, at 30-day follow-up and at 1-year follow-up	Single Leaflet Device Attachment
Conversion to surgery or re-imaging of the MV	During the index procedure, at 30-day follow-up and at 1-year follow-up	Conversion to surgery (urgently or elective) or re-imaging of the MV
Stratification by MR etiology	During the index procedure, at 30-day follow-up and at 1-year follow-up	Primary vs. Secondary MR
Combined endpoint of mortality, repeat MV intervention or HHF	During the index procedure, at 30-day follow-up and at 1-year follow-up	Assessed at 30-days and 1-year
Quality of Life	At 30-day follow-up and at 1-year follow-up	Measured using the KCCQ Score
Exertional dyspnea	At 30-day follow-up and at 1-year follow-up	NYHA functional class

Trial Locations

Locations (1)

LMU Klinikum; 🇩🇪 Munich, Bavaria, Germany