3-Dimensional Simulation Guided Transcatheter Aortic Valve Replacement in Aortic Regurgitation(DIGITAL)
NCT07398911 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 354
Last updated 2026-02-10
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.
Conditions
- Aortic Regurgitation
Interventions
- DEVICE
-
3D simulation technique
using 3D simulation technique
Sponsors & Collaborators
-
Fu Wai Hospital, Beijing, China
collaborator OTHER -
West China Hospital
collaborator OTHER -
Beijing Anzhen Hospital
collaborator OTHER -
General Hospital of Ningxia Medical University
collaborator OTHER -
Chinese Academy of Medical Sciences, Fuwai Hospital
collaborator OTHER -
People's Hospital of Xinjiang Uygur Autonomous Region
collaborator OTHER -
Henan Provincial Chest Hospital
collaborator OTHER -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
collaborator OTHER -
Fujian Medical University Union Hospital
collaborator OTHER -
Guangdong Provincial People's Hospital
collaborator OTHER -
Xinqiao Hospital of Chongqing
collaborator OTHER -
The Affiliated Hospital of Qingdao University
collaborator OTHER -
First Affiliated Hospital Xi'an Jiaotong University
collaborator OTHER -
Yan'an Hospital of Kunming City
collaborator UNKNOWN -
Dong'e People's Hospital
collaborator UNKNOWN -
Xijing Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-30
- Primary Completion
- 2026-05-30
- Completion
- 2026-05-30
Countries
- China
Study Locations
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