Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter aortic valve replacement: Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.

Study summary

This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.

Eligibility

Primary outcome measure(s)

• Device success — Perioperative period
  (1) freedom from mortality; (2) successful access, delivery of the device, and retrieval of the delivery system; (3) correct positioning of a single prosthetic heart valve into the proper anatomical location; (4) freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; (5) intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
• 30-day all-cause mortality — 30 days
  30-day all-cause mortality
• 30-day adverse aortic events — 30 days
  Aortic-related death, aortic dissection, or aortic rupture.

Trial sites (3)

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