By InvitationNot Applicable

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

China354 participantsStarted 2025-07-30

Plain-language 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.

Who can participate

Age range65 Years

SexALL

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Inclusion criteria

✓. Age ≥ 65 years;
✓. Symptomatic severe native aortic regurgitation;
✓. Aortic valve anatomy assessed by investigator as suitable for transcatheter aortic valve replacement ;
✓. Subjects signed a written informed consent and agreed to cooperate with all follow-up examinations.

Exclusion criteria

✕. Active endocarditis;
✕. Acute myocardial infarction or unstable angina pectoris, or severe coronary stenosis requiring coronary revascularization within 3 months;
✕. Stroke or TIA (transient ischemic attack) within the past 3 months;
✕. Any intracardiac mass, left ventricular or atrial thrombus, vegetation detected by echocardiography;
✕. Severe obstructive hypertrophic cardiomyopathy (LVOTG peak ≥ 30 mmHg at rest); Note: Literature Basis: Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy 2023
✕. History of bleeding tendency or coagulopathy or refusal of blood transfusion;
✕. Active gastric ulcer or active gastrointestinal (GI) bleeding within 3 months;
✕. Presence of contraindication to anticoagulation or antiplatelet;

What they're measuring

Coaxial ratio of prosthetic aortic valve

Timeframe: 12 months

Trial details

NCT IDNCT07398911

SponsorXijing Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

View on ClinicalTrials.gov More Aortic Regurgitation trials