Clinical Trial

3-Dimensional Simulation Guided Transcatheter Aortic Valve Replacement in Aortic Regurgitation(DIGITAL)

Study acronym: DIGITAL
Enrolling by Invitation
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Record status
This record was last updated February 10, 2026 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study will evaluate the safety and efficacy of postmarket bioprosthetic aortic valve in patients with severe aortic regurgitation undergoing transapical transcatheter aortic valve replacement based on 3D simulation technology using a prospective, randomized controlled study.
Trial Details
NCT Number NCT07398911
Lead Sponsor Xijing Hospital
Collaborators: Fu Wai Hospital, Beijing, China, West China Hospital, Beijing Anzhen Hospital, General Hospital of Ningxia Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Henan Provincial Chest Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, Xinqiao Hospital of Chongqing, The Affiliated Hospital of Qingdao University, First Affiliated Hospital Xi'an Jiaotong University, Yan'an Affiliated Hospital of Kunming Medical University, Dong'e People's Hospital
Conditions Aortic Regurgitation
Enrollment 354 participants
Start Date 2025-07-30
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-10