Outcome Registry and Assessment of New Edge-to-Edge Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ORANGE- TEER (Outcome Registry and Assessment of New Edge-to-Edge Repair)
Overview
The goal of this observational study is to learn about the long-term effects of Edge-tot-edge repair of all the patients of AmsterdamUMC, to treat their Mitral regurgitation (MR). The main question it aims to answer is: The patient selection process could be optimized. Participants are already receiving edge-to-edge repair as part of their standard medical care and will additionally complete quality-of-life survey questions.
Detailed description
Mitral regurgitation (MR) affects more than 10% of individuals over the age of 75, and with an aging population, its prevalence is expected to continue rising in the coming years. Treatment options include surgical repair, surgical replacement, medical therapy, cardiac resynchronization therapy (CRT), or transcatheter valve repair. For percutaneous mitral valve repair, the transcatheter edge-to-edge repair (M-TEER) technique is the preferred approach. This technique involves the use of the MitraClip (Abbott) and PASCAL (Edwards) devices, which are derived from the surgical Alfieri technique.
Since 2009, the M-TEER procedure has been performed in patients who, based on assessment by the heart team and mitral valve team, are deemed unsuitable for surgery but are eligible for this percutaneous treatment.
Using data from all patients undergoing M-TEER at Amsterdam UMC, the investigators aim to conduct research focused on improving patient selection and alleviating symptoms associated with mitral valve disease.
Primary outcome measures
- Change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time frame: Baseline and 6 months]
- Change in quality of life measured by the 36-Item Short Form Survey (SF-36) [Time frame: Baseline and 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT07108907 · 2025.0301