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

LMU Klinikum

Status: Enrolling

Conditions: Valvular Heart Disease; Mitral Regurgitation; Heart Failure

Treatments: Device: Transcatheter mitral valve edge-to-edge repair (M-TEER)

Study type: Interventional

Funder types: Other

Identifiers

NCT06634121

LEAFLET I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

MitraClip

Active Comparator group

Treatment:

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

PASCAL

Active Comparator group

Treatment:

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