Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation (NCT06467110) | Clinical Trial Compass
By InvitationNot Applicable
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation
China118 participantsStarted 2021-10-15
Plain-language summary
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.in patients with moderate-severe or severe degenerated mitral regurgitation (DMR).
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
. Porcelain aorta or active ascending aortic plaque
. Mediastinum treated with radiotherapy
. Past mediastinitis
. Left ventricular ejection fraction (LVEF) \<40%
. Presence of a patent coronary bypass implant
. Acceptance of two or more cardiothoracic surgeries
. Liver cirrhosis
. Other surgical risk factors
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
1
1. Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery
Timeframe: 12 months after surgery
Trial details
NCT IDNCT06467110
SponsorShanghai Shenqi Medical Technology Co., Ltd