Mi-thos® Transcatheter Mitral Valve Replacement Study
Recruiting
N/A
Interventional Study
Mitral Valve Regurgitation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 65 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 122 (estimated)
- Sponsor
- Shanghai NewMed Medical Co., Ltd. · Industry
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About This Trial
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Trial Locations
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Eligibility Criteria
Inclusion 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 for…
Contacts