NCT07398911Enrolling By InvitationNot Applicable
3-Dimensional Simulation Guided Transcatheter Aortic Valve Replacement in Aortic Regurgitation(DIGITAL)
Xijing Hospital1 site in 1 country354 target enrollmentStarted: July 30, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 354
- Locations
- 1
- Primary Endpoint
- Coaxial ratio of prosthetic aortic valve
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All of the following conditions must be met for inclusion:
- •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
- •Patients meeting any of the following exclusion criteria were not included:
- •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;
- •Complicated with severe other valve diseases requiring concurrent surgical intervention;
- •Prior aortic valve graft (mechanical or bioprosthetic);
- •Severe left ventricular dysfunction, left ventricular ejection fraction < 30%;
- •Hepatic encephalopathy or acute active hepatitis;
- •Renal dysfunction (eGFR < 30ml/min calculated according to Cockcroft-Gault formula) and/or ongoing renal replacement therapy;
- •Patients with severe dementia and other poor compliance, unable to ensure the completion of the investigator;
- •Emergency surgery required for any reason;
- •Known hypersensitivity to contrast agents or nitinol memory alloys or porcine products;
- •Patients who are pregnant or plan to become pregnant, or are taking estrogen or estrogen-like drugs (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study);
- •Other patients considered unsuitable for this clinical study by the investigator;
Arms & Interventions
Test group
Experimental
Using 3D simulation technique
Intervention: 3D simulation technique (Device)
Control group
No Intervention
Not using 3D simulation technique
Outcomes
Primary Outcomes
Coaxial ratio of prosthetic aortic valve
Time Frame: 12 months
Definition: A coaxial index of less than 4 degrees or a coaxial angle of less than 10 degrees is considered coaxial if one of them is met, and the ratio of coaxial prosthetic aortic valves in the two groups test group (with 3D simulation technique) or control group (without 3D simulation technique) is calculated, respectively Coaxial rate per group = number of coaxial aortic valve prostheses per group/total number of cases per group 100%
Secondary Outcomes
- All-cause death, Disabling stroke, Myocardial infarction, and Heart failure(30 days)
- Technical success(immediate postoperative)
- All-cause mortality(30 days,12 months)
- Device success(30 days)
- Myocardial infarction(before discharge, 30 days, 12 months)
- Incidence of coronary obstruction(before discharge)
- CT imaging changes(12 months)
- New York Heart Association Functional Classification(before discharge, 30 days , 12 months)
- Evaluation cardiac function by electrocardiography(30 days,12 months)
- Evaluation of bioprosthesis performance by echocardiography(30 days,12 months)
- Contents of evaluation: including valve displacement, valve embolism and ectopic valve deployment(immediate postoperative)
- Major Cardiac Structural Complications(before discharge, 30 days)
Investigators
Jian Yang
Chief Physician
Xijing Hospital
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 4
Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR）Aortic StenosisNCT07317804China National Center for Cardiovascular Diseases212
Recruiting
Not Applicable
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)Aortic StenosisSymptomatic Severe Native Aortic StenosisNCT07278310MiRus1,025
Not yet recruiting
Not Applicable
Zhicheng TAVR RobotNCT07392359Zhicheng Medical Technology (Jiaxing) Co, Ltd158
Recruiting
Not Applicable
Comparative Research of Y-Incision vs. Standard Techniques for Aortic Root EnLargementNCT07368322willner nadav MD90
Active, not recruiting
Not Applicable
Electrophysiological Outcomes After Transcatheter Aortic Valve ReplacementArrhythmiaNCT07390513Chinese Academy of Medical Sciences, Fuwai Hospital1,000