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

Not Applicable

Not yet recruiting

• Conditions: Mitral Regurgitation Functional
• Interventions: Device: TEER; Drug: GDMT

• Registration Number: NCT07197021
• Lead Sponsor: Sun Yat-sen University

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 (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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-20
• Study First Submitted QC: 2025-09-20
• Last Update Submitted: 2025-09-20
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Study Start: 2025-10-01
• Primary Completion: 2027-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Moderate functional mitral regurgitation
2. HG-induced severe functional mitral regurgitation
3. Left ventricular ejection fraction (LVEF) between 20% to 50%
4. Left ventricular end-systolic diameter (LVESD) ≤70 mm

Exclusion Criteria

1. Stage D heart failure per ACC/AHA guidelines with hemodynamic instability or cardiogenic shock
2. Untreated symptomatic coronary artery disease requiring revascularization
3. Chronic obstructive pulmonary disease (COPD) requiring continuous oxygen therapy or long-term corticosteroids therapy
4. Severe pulmonary hypertension or moderate-to-severe right ventricular dysfunction
5. Aortic or tricuspid valve disease requiring surgical or transcatheter intervention
6. Life expectancy <12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEER	TEER	TEER
TEER	GDMT	TEER
Control group	GDMT	GDMT

Primary Outcome Measures

Name	Time	Method
Rehospitalization rate	24 months	Rehospitalization rate within 24 months

Secondary Outcome Measures

Name	Time	Method
KCCQ	24 months	Range of 0-100, with higher scores indicating better health status
NYHA class	24 months	I-IV
6-min walk test	24 months	\>500 m: Normal exercise capacity 350-500 m: Mild impairment 150-350 m: Moderate impairment \<150 m: Severe impairment
MACE	24 months	Cardiovascular Death, Myocardial Infarction, Stroke

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China