Outcomes after new edge-to-edge mitral valve repair
Official title: ORANGE- TEER (Outcome Registry and Assessment of New Edge-to-Edge Repair)
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT07108907 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Status | Recruiting |
| Started | July 10, 2025 |
| Main results expected | January 1, 2030 |
| Study ends | January 1, 2035 |
| Registry record updated | August 7, 2025 |
| Trial ID | NCT07108907 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Amsterdam UMC
Amsterdam, North Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Abby E Geerlings, MD
- Email: a.e.geerlings@amsterdamumc.nl
- Phone: +31205669467
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Surgical implantation of a polymer prosthetic mitral or aortic valve
This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.
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GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation
This trial will try the GeminiOne TEER system to treat adults with severe, symptomatic mitral regurgitation who are high surgical risk or have not improved with medical therapy.
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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.