Mi-thos® Transcatheter Mitral Valve Replacement Study
ConditionMitral Valve Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorShanghai NewMed Medical Co., Ltd.
About this trial
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Eligibility criteria
Qualifiers
Severe mitral valve regurgitation ≥ 3+;
High surgical risk fot open mitral valve surgery;
Age ≥ 65 years old;
Life expectancy > 12 months;
Disqualifiers
Previous cardiac mitral valve surgery;
Active infections requiring antibiotic therapy;
Clinically significant untreated Coronary Artery Disease (CAD);
Pulmonary hypertension （Pulmonary systolic pressure > 70 mmHg）;
Trial design
Treatments tested in this trial
- Mi-thos® valve and transapical delivery system
Treatment groups
122 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov