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

NCT07019935 | Recruiting

• 1 other identifier: AMPLE-TEER study
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mitral Insufficiency

Outcome Measures

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%).

  Through study completion, an average of 5 years

Study Arms (1)

Patients undergoing TEER

Adult MR patients undergoing TEER during hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization.
• Aged over 18 yrs.

You may not qualify if:

• Patients unable to provide written consent.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaodong Zhuang

CONTACT

+86 13760755035; zhuangxd3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: October 1, 2021
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)