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

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2028-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mitral Regurgitation Valvular Heart Disease Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MitraClip

Group Type ACTIVE_COMPARATOR

Transcatheter mitral valve edge-to-edge repair (M-TEER)

Intervention Type DEVICE

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.

PASCAL

Group Type ACTIVE_COMPARATOR

Transcatheter mitral valve edge-to-edge repair (M-TEER)

Intervention Type DEVICE

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.

Interventions

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Transcatheter mitral valve edge-to-edge repair (M-TEER)

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No