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New treatment option for Mitral Regurgitation
Official title Valveclip® Transcatheter Mitral Valve Repair Study
ClinicalTrials.gov ID: NCT05021614
What this study is testing
- What it's testing
- The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);
- Age≥70 years; or patients who are 60\~70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or...
- The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation);
- The width of the mitral valve prolapsed area is ≤15mm, Height of Prolapse ≤10mm or coaptation depth≤11mm, coaptation height≥2mm, effective length of...
- Effective mitral valve orifice area≥ 4.0cm2;
You likely can't join if
- Previous cardiac mitral valve surgery;
- Patients with Infective endocarditis or having an active infection;
- Patients with mitral regurgitation caused by pure mitral stenosis;
- Combined with untreated severe coronary artery disease
- Pulmonary hypertension (pulmonary artery systolic pressure\>70mmHg);
- Patients with severe right heart failure;
See the full eligibility criteria
- Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);
- Age≥70 years; or patients who are 60\~70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or cannot tolerate traditional thoracotomy; 4) Left ventricular ejection...
- The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation);
- The width of the mitral valve prolapsed area is ≤15mm, Height of Prolapse ≤10mm or coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\>1cm (conforming to EVEREST II...
- Effective mitral valve orifice area≥ 4.0cm2;
- No obvious calcification of the mitral valve annulus and valve leaflets;
- Patient's anatomical conditions allow transseptal approach.
- Previous cardiac mitral valve surgery;
- Patients with Infective endocarditis or having an active infection;
- Patients with mitral regurgitation caused by pure mitral stenosis;
- Combined with untreated severe coronary artery disease
- Pulmonary hypertension (pulmonary artery systolic pressure\>70mmHg);
- Patients with severe right heart failure;
- Patients are extremely weak and cannot tolerate general anesthesia or are in shock that circulatory support is needed;
- Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis;
- Patients receiving chronic dialysis;
- Patients with clear coagulation dysfunction and severe coagulopathy;
- Patients with clear contraindications to anticoagulant drugs;
- Patients with stroke or transient ischemic attack within 30 days;
- Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
- Patients who require surgery or treatment therapy for other valvular lesions;
- Patients with severe macrovascular lesions requiring surgical treatment;
- Patients' imaging examinations suggest that the anatomy of the heart and valves are inappropriate;
The study team makes the final eligibility decision.
Where it's taking place
- Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.