Status:
NOT_YET_RECRUITING
Transcatheter Edge-to-Edge Repair In Moderate and Exertional-Induced Severe MR (TIMER)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Mitral Regurgitation Functional
Eligibility:
All Genders
Phase:
EARLY_PHASE1
Brief Summary
Transcatheter Edge-to-Edge Repair (TEER) has become an established alternative for the treatment of severe mitral regurgitation (MR). RESHAPE trial indicated that patients with moderate functional MR ...
Eligibility Criteria
Inclusion
- Moderate functional mitral regurgitation
- HG-induced severe functional mitral regurgitation
- Left ventricular ejection fraction (LVEF) between 20% to 50%
- Left ventricular end-systolic diameter (LVESD) ≤70 mm
Exclusion
- Stage D heart failure per ACC/AHA guidelines with hemodynamic instability or cardiogenic shock
- Untreated symptomatic coronary artery disease requiring revascularization
- Chronic obstructive pulmonary disease (COPD) requiring continuous oxygen therapy or long-term corticosteroids therapy
- Severe pulmonary hypertension or moderate-to-severe right ventricular dysfunction
- Aortic or tricuspid valve disease requiring surgical or transcatheter intervention
- Life expectancy \<12 months
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07197021
Start Date
October 1 2025
End Date
September 30 2030
Last Update
September 29 2025
Active Locations (1)
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1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080