RecruitingNot Applicable

TEER for Severe DMR of Low to Intermediate Surgery Risk

China160 participantsStarted 2024-01-01

Plain-language summary

To investigate the efficacy and safety of transcatheter mitral valve edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR) patients of low to intermediate surgery risk.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. age ≥ 18 years old
. DMR ≥ grade 3+ according to UCG integrative approach, referring to the following quantitative indicators: 1) effective regurgitant orifice area (EROA) ≥0.3cm\^2; 2) regurgitant volume (RVol) ≥45ml; 3) regurgitant fraction (RF) ≥40%.
. symptomatic heart failure ( New York Heart Association (NYHA) class II-IV ), or asymptomatic heart failure with left ventricular end systolic dimension (LVESd) ≥40mm or ejection fraction (EF) ≤60%, or new-onset atrial fibrillation, or resting pulmonary artery systolic pressure (PASP) \>50mmHg.
. The patient with American Association of Thoracic Surgeons Score (STS) \<8 has surgical indications evaluated by cardiac team.
. The patient has signed an informed consent form and agreed to regular follow-up for at least 1 year.

Exclusion criteria

. active infective endocarditis especially occurring in the mitral valve area, or mitral valve perforation.
. rheumatic mitral valve disease, mitral stenosis or mitral valve orifice area \< 4mm\^2.
. combined valve lesions requiring surgery, e.g. severe tricuspid regurgitation or aortic valve disease.
. the present of tumour, thrombus or redundant organisms in the heart chambers.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cumulative composite event rate of the main adverse events

Timeframe: time of operation to 30 days after operation

cumulative composite event rate of all-cause death and worsening heart failure

Timeframe: time of operation to 24 months after operation

Trial details

NCT IDNCT06162780

SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Yangxin Chen, PhD

8681332360 chenyx39@mail.sysu.edu.cn

View on ClinicalTrials.gov More Mitral Regurgitation trials