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 range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;