Predicting afterload mismatch after transcatheter mitral edge-to-edge repair
Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER Study)
It will test a model to predict which adults having transcatheter mitral valve edge-to-edge repair will develop afterload mismatch after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07019935 on ClinicalTrials.gov |
What this trial studies
AMPLE-TEER is a prospective observational effort to develop a predictive model for afterload mismatch in patients undergoing transcatheter mitral valve edge-to-edge repair (TEER). The study will enroll adults treated with TEER at The First Affiliated Hospital of Sun Yat-sen University and collect clinical, echocardiographic, and hemodynamic data before, during, and after the procedure. Investigators will analyze these variables to identify factors associated with post-procedural afterload mismatch and adverse ventricular remodeling. The aim is to enable earlier intervention and better postoperative management for high-risk patients.
Who should consider this trial
Good fit: Adults over 18 undergoing TEER at the enrolling hospital who can provide written informed consent are the intended participants.
Not a fit: Patients not undergoing TEER, those unable to give written consent, or those with incomplete follow-up/data are unlikely to benefit from this predictive approach.
Why it matters
Potential benefit: If successful, the predictive model could help clinicians identify patients at high risk for afterload mismatch early so they can adjust care to reduce ventricular remodeling, hospitalizations, and mortality.
How similar studies have performed: Prior observational reports have identified risk factors for afterload mismatch after TEER, but comprehensive prospective predictive models are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xiaodong Zhuang
- Email: zhuangxd3@mail.sysu.edu.cn
- Phone: +86 13760755035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.