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

NCT07197021 | Not Yet Recruiting Early Phase 1 DMC FDA Device

• 1 other identifier: TIMER
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation Functional

Keywords

hand grip; TEER; moderate

Outcome Measures

Primary Outcomes (1)

• Rehospitalization rate

  Rehospitalization rate within 24 months

  24 months

Secondary Outcomes (4)

• KCCQ

  24 months

• NYHA class

  24 months

• 6-min walk test

  24 months

• MACE

  24 months

Other Outcomes (1)

• Safety Outcome

  24 months

Study Arms (2)

TEER

EXPERIMENTAL

TEER

Device: TEER; Drug: GDMT

Control group

PLACEBO COMPARATOR

GDMT

Drug: GDMT

Interventions

TEER DEVICE

TEER

TEER

GDMT DRUG

GDMT

Control group; TEER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Xiaodong Zhuang, MD

CONTACT

020-89998001; zhuangxd3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The first affiliated hospital of Sun Yat-Sen University

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)