NCT06634121

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

Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation
• Valvular Heart Disease
• Heart Failure

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: Germany