Comparing MitraClip and PASCAL for treating mitral regurgitation
Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population
NA · LMU Klinikum · NCT06634121
This study is testing two devices, MitraClip and PASCAL, to see which one works better for treating mitral regurgitation in patients who need this heart procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LMU Klinikum (other) |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT06634121 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in outcomes between two transcatheter devices, MitraClip and PASCAL, used for edge-to-edge repair of the mitral valve in patients with mitral regurgitation. It aims to evaluate their effectiveness in a diverse patient population, including those with complex anatomical conditions. The study will include patients who are recommended for this procedure by a heart team and will assess the performance of both devices in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been recommended for transcatheter mitral valve repair by a heart team.
Not a fit: Patients with mitral stenosis, cardiogenic shock, active endocarditis, or those participating in another interventional cardiology study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective treatment option for patients with mitral regurgitation, potentially improving their outcomes.
How similar studies have performed: While both devices have been used successfully in less complex cases, this study aims to explore their effectiveness in a broader and more complex patient population, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Munich, Bavaria
- LMU Klinikum — Munich, Bavaria, Germany (RECRUITING)
Study contacts
- Principal investigator: Jörg Hausleiter, Prof. Dr. — LMU Klinikum
- Study coordinator: Jörg Hausleiter, Prof. Dr.
- Email: Joerg.Hausleiter@med.uni-muenchen.de
- Phone: +4989440072361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mitral Regurgitation, Valvular Heart Disease, Heart Failure, TEER, MitraClip, PASCAL