Outcomes after new edge-to-edge mitral valve repair
ORANGE- TEER (Outcome Registry and Assessment of New Edge-to-Edge Repair)
This project will follow people with mitral regurgitation who receive transcatheter edge-to-edge repair at Amsterdam UMC to see how they do long-term and whether patient selection can be improved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT07108907 on ClinicalTrials.gov |
What this trial studies
This observational registry collects clinical data and quality-of-life questionnaires from all patients treated with transcatheter mitral edge-to-edge repair (M-TEER) at Amsterdam UMC, using devices such as MitraClip and PASCAL. Patients are treated as part of routine care and then followed over time without additional experimental interventions. The dataset will be used to study long-term outcomes, symptoms, and factors linked to better or worse results. Findings are intended to inform which patients are most likely to benefit from M-TEER and to guide clinical decision-making.
Who should consider this trial
Good fit: Adults (age ≥18) with mitral regurgitation who are accepted for transcatheter edge-to-edge repair at Amsterdam UMC and can complete questionnaires are ideal candidates.
Not a fit: Patients not treated with M-TEER, those unable to complete questionnaires, or individuals treated outside Amsterdam UMC are unlikely to receive direct benefit from this registry.
Why it matters
Potential benefit: If successful, the registry can help clinicians identify which patients are most likely to benefit from M-TEER and improve symptom relief and long-term outcomes.
How similar studies have performed: Previous device registries and clinical trials of M-TEER devices like MitraClip and PASCAL have shown symptom improvement and helped refine patient selection, though ongoing registry data provide additional long-term insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria Inclusion Criteria: * Age ≥ 18 years * Accepted for M-TEER (Minimally Invasive Transcatheter Edge-to-Edge Repair) procedure Exclusion Criteria: \- Unable to complete the questionnaires
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Abby E Geerlings, MD
- Email: a.e.geerlings@amsterdamumc.nl
- Phone: +31205669467
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.