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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Mi-thos® valve and transapical delivery system
DeviceTranscatheter mitral valve replacement system
Treatment groups
122 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from all-cause mortality
All-cause mortality after TMVR
Time frame
1 yearSecondary outcomes
1
Freedom from all-cause mortality
All-cause mortality after TMVR
Time frame
30 days, 6months, 2-5 years2
Severe adverse event rate
Severe adverse events rate after TMVR
Time frame
30 days, 6months, 1 year, 2-5 years3
NYHA Heart Function Rating
NYHA Heart Function Rating after TMVR
Time frame
30 days, 6months, 1 year, 2-5 years4
Kansas City Cardiomyopathy score
Kansas City Cardiomyopathy score after TMVR
Time frame
30 days, 6months, 1 year, 2-5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov