Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER)
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 Insufficiency. Basic parameters: from 18 years · 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER Study)
Overview
Mitral regurgitation (MR) is one of the most common valvular heart diseases in China, causing heart failure. Patients with moderate to severe MR have a very poor clinical prognosis if no intervention is performed. When symptoms are still poorly controlled after guideline-directed medical therapy (GDMT) or when surgical intervention is not suitable, transcatheter mitral valve edge-to-edge repair (TEER) can improve the patient's quality of life and reduce the hospitalization rate and mortality rate. However, some patients develop into afterload mismatch (AM) after TEER, persistent adverse ventricular remodeling, and a high mortality rate, which limits the surgical benefits of TEER surgery in these MR patients. Therefore, how to scientifically predict AM and intervene as early as possible has become a research hotspot for optimizing the postoperative management of TEER patients. Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER) study is a prospective cohort study including adult patients undergoing TEER during hospitalization. We aim to evaluate whether the patients develop into AM after TEER, evaluate the prognostic risk factors of AM and construct a prognostic clinical model to guide clinical decision-making.
Primary outcome measures
- Afterload mismatch [Time frame: Through study completion, an average of 5 years]
Eligibility criteria
Inclusion criteria
- Patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization.
- Aged over 18 yrs.
Exclusion criteria
- Patients unable to provide written consent.
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
China · 1 center
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07019935 · AMPLE-TEER study