Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation

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 groups