NCT07019935 Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER)
| NCT ID | NCT07019935 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Mitral Insufficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2030-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-10-01 with a primary completion date of 2030-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07019935 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07019935 currently recruiting?
Yes, NCT07019935 is actively recruiting participants. Contact the research team at zhuangxd3@mail.sysu.edu.cn for enrollment information.
Where is the NCT07019935 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07019935 clinical trial?
NCT07019935 is sponsored by Sun Yat-sen University. The trial plans to enroll 1,000 participants.