ConditionAortic Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorNanjing First Hospital, Nanjing Medical University
About this trial
Prospective, multicenter, randomized trial.
Eligibility criteria
Qualifiers
Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) > 65mm or left ventricular end-systolic dimension (LVESD) > 50mm;
Severe aortic valve regurgitation, and mean pressure gradient < 20mmHg; Annular perimeter ≤ 85 mm;
The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
Severe aorta calcification or active ascending aorta atherosclerotic plaque
Disqualifiers
Age < 60 years old;
Ascending aorta diameter >45mm;
Coronary multi-vessel disease (SYNTAX score >32);
Life expectancy <1 year;
Trial design
Treatments tested in this trial
- Transcatheter Aortic Valve Implantation
- Medical therapy
Treatment groups
210 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov