Comparing MitraClip and PASCAL for treating mitral regurgitation
Official title: Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population
Run by LMU Klinikum · NCT06634121 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | LMU Klinikum Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | October 9, 2024 |
| Trial ID | NCT06634121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been recommended for transcatheter mitral valve repair by a heart team.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.