Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization.

Aged over 18 yrs.

Disqualifiers

Patients unable to provide written consent.

Trial population

Adult patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization were enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Patients undergoing TEER

Trial outcomes

Primary outcomes

1

Afterload mismatch

The increase in the patient's left ventricular end-diastolic volume index (LVEDVi) after transcatheter mitral valve edge-to-edge repair (TEER) was 10% or more compared with before (dLVEDVi ≥10%).

Time frame
Through study completion, an average of 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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