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New treatment option for Mitral Valve Regurgitation
Official title Mi-thos® Transcatheter Mitral Valve Replacement Study
ClinicalTrials.gov ID: NCT04195984
What this study is testing
- What it's testing
- To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Severe mitral valve regurgitation ≥ 3+;
- High surgical risk fot open mitral valve surgery;
- Age ≥ 65 years old;
- Life expectancy \> 12 months;
- As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
You likely can't join if
- Previous cardiac mitral valve surgery;
- Active infections requiring antibiotic therapy;
- Clinically significant untreated Coronary Artery Disease (CAD);
- Pulmonary hypertension （Pulmonary systolic pressure \> 70 mmHg）;
- Patients with severe right heart failure;
- Left ventricular ejection fraction \<25%;
See the full eligibility criteria
- Severe mitral valve regurgitation ≥ 3+;
- High surgical risk fot open mitral valve surgery;
- Age ≥ 65 years old;
- Life expectancy \> 12 months;
- As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
- Patients sign an informed consent form.
- Previous cardiac mitral valve surgery;
- Active infections requiring antibiotic therapy;
- Clinically significant untreated Coronary Artery Disease (CAD);
- Pulmonary hypertension （Pulmonary systolic pressure \> 70 mmHg）;
- Patients with severe right heart failure;
- Left ventricular ejection fraction \<25%;
- Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
- Dialysis patient;
- Patients with severe coagulopathy;
- Patients with contraindications to anticoagulant drugs;
- Patients with stroke or transient ischemic 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 disease requiring surgical treatment;
- Patients with more than 70% of carotid stenosis;
- To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;
- Patients with severe neurological disorders affecting cognitive ability;
- Patients with severe thoracic deformities.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, 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, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China; Xi’an, Shanxi, 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.