NCT07197021

Transcatheter Edge-to-Edge Repair In Moderate and Exertional-Induced Severe MR (TIMER)

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 (FMR) and heart failure (HF) might benefit from TEER. However, it still not clear that TEER is effective for which subset of patients with FMR. Hand-Gripping (HG), characterized with an increased venous return, preservation or increase of left ventricular (LV) afterload and systemic vascular resistance, has been identified as a means of stress test to identify exertion-induced mitral regurgitation. Most importantly, compared to exercise stress testing via treadmill running or cycling in patients with moderate FMR, HG demonstrates significantly higher feasibility and safety. HG-induced severe MR reflects the reversibility of the regurgitation under stress, suggesting that reducing MR through TEER might alleviate LV volume overload, improve cardiac efficiency, and mitigate symptoms, which need to be validated in this trial. TIMER is a multi-center, randomized, double blind, placebo-controlled trial. A total of 300 patients with moderate and exertional-induced severe MR will be randomized in a 1:1 ratio to the treatment with TEER and guideline-directed medical therapy (GDMT) or GDMT only. The primary endpoint of this study is rehospitalization within 24 months.

Conditions

• Mitral Regurgitation Functional

Interventions

Type	Name	Description
DEVICE	TEER	TEER
DRUG	GDMT	GDMT

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-09-30
• Completion: 2030-09-30
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study