Transcatheter Edge-to-Edge Repair In Moderate and Exertional-Induced Severe MR (TIMER)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEER, GDMT.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation Functional. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device TEER
TEER - Drug GDMT
GDMT
Primary outcome measures
- Rehospitalization rate [Time frame: 24 months]
Secondary outcome measures (4)
- KCCQ [Time frame: 24 months]
- NYHA class [Time frame: 24 months]
- 6-min walk test [Time frame: 24 months]
- MACE [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
Publications
- Giustino G, Camaj A, Kapadia SR, Kar S, Abraham WT, Lindenfeld J, Lim DS, Grayburn PA, Cohen DJ, Redfors B, Zhou Z, Pocock SJ, Asch FM, Mack MJ, Stone GW. Hospitalizations and Mortality in Patients With Secondary Mitral Regurgitation and Heart Failure: The COAPT Trial. J Am Coll Cardiol. 2022 Nov 15;80(20):1857-1868. doi: 10.1016/j.jacc.2022.08.803. PMID 36357085
- Alachkar MN, Kirschfink A, Grebe J, Almalla M, Frick M, Milzi A, Moersen W, Becker M, Marx N, Altiok E. Dynamic handgrip exercise for the evaluation of mitral valve regurgitation: an echocardiographic study to identify exertion induced severe mitral regurgitation. Int J Cardiovasc Imaging. 2021 Mar;37(3):891-902. doi: 10.1007/s10554-020-02063-5. Epub 2020 Oct 16. PMID 33064244
Identifiers
NCT: NCT07197021 · TIMER