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

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 Overview

• Status: Enrolling by invitation
• Conditions: Aortic Regurgitation
• Intervention / Treatment: Device: 3D simulation technique

• Study Type: Interventional
• Enrollment (Estimated): 354
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi’an, Shanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All of the following conditions must be met for inclusion:

  1. Age ≥ 65 years;
  2. Symptomatic severe native aortic regurgitation;
  3. Aortic valve anatomy assessed by investigator as suitable for transcatheter aortic valve replacement ;
  4. 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:

  1. Active endocarditis;
  2. Acute myocardial infarction or unstable angina pectoris, or severe coronary stenosis requiring coronary revascularization within 3 months;
  3. Stroke or TIA (transient ischemic attack) within the past 3 months;
  4. Any intracardiac mass, left ventricular or atrial thrombus, vegetation detected by echocardiography;
  5. Severe obstructive hypertrophic cardiomyopathy (LVOTG peak ≥ 30 mmHg at rest); Note: Literature Basis: Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy 2023
  6. History of bleeding tendency or coagulopathy or refusal of blood transfusion;
  7. Active gastric ulcer or active gastrointestinal (GI) bleeding within 3 months;
  8. Presence of contraindication to anticoagulation or antiplatelet;
  9. Complicated with severe other valve diseases requiring concurrent surgical intervention;
  10. Prior aortic valve graft (mechanical or bioprosthetic);
  11. Severe left ventricular dysfunction, left ventricular ejection fraction < 30%;
  12. Hepatic encephalopathy or acute active hepatitis;
  13. Renal dysfunction (eGFR < 30ml/min calculated according to Cockcroft-Gault formula) and/or ongoing renal replacement therapy;
  14. Patients with severe dementia and other poor compliance, unable to ensure the completion of the investigator;
  15. Emergency surgery required for any reason;
  16. Known hypersensitivity to contrast agents or nitinol memory alloys or porcine products;
  17. 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);
  18. Other patients considered unsuitable for this clinical study by the investigator;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Using 3D simulation technique	Device: 3D simulation technique; using 3D simulation technique
No Intervention: Control group; Not using 3D simulation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coaxial ratio of prosthetic aortic valve	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%	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death, Disabling stroke, Myocardial infarction, and Heart failure	Number of patients that had any of these events	30 days
Technical success	No operative mortality;Successful puncture, device delivery and delivery system retrieval;Correct positioning and release of a single bioprosthetic aortic valve to the appropriate anatomical location;No device-related procedures or interventions, no major vascular or access-related complications, and no structural cardiac complications	immediate postoperative
All-cause mortality	Rate of all-cause mortality	30 days,12 months
Device success	Technical success • Freedom from death • No device-related procedures or interventions, no major vascular or access-related complications, and no structural cardiac complications • The performance of the bioprosthetic aortic valve meets clinical requirements (mean aortic valve gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥0.25 and < moderate aortic regurgitation)	30 days
Myocardial infarction	Number of patients that had event	before discharge, 30 days, 12 months
Incidence of coronary obstruction	Number of patients that had event	before discharge
CT imaging changes	1) New aortic sinus volume formed after prosthetic valve implantation2) Low density leaflet thickening/leaflet thrombosis on prosthetic valve	12 months
New York Heart Association Functional Classification		before discharge, 30 days , 12 months
Evaluation cardiac function by electrocardiography	Left ventricular ejection fraction (%)	30 days,12 months
Evaluation cardiac function by electrocardiography	Left ventricular end diastolic diameter (mm)	30 days,12 months
Evaluation of bioprosthesis performance by echocardiography	Using the following measures:Aortic Valve Mean Gradient (cm2)	30 days,12 months
Evaluation of bioprosthesis performance by echocardiography	Using the following measures:Transaortic peak velocity	30 days,12 months
Evaluation of bioprosthesis performance by echocardiography	Using the following measures:Transaortic Central Regurgitation Severity	30 days,12 months
Evaluation of bioprosthesis performance by echocardiography	Using the following measures:Perivalvular Leak Severity	30 days,12 months
Contents of evaluation: including valve displacement, valve embolism and ectopic valve deployment	Valve Dislodgement: Following initial correct positioning, the prosthesis moved upward or downward within the aortic annulus from its initial position without valve embolization Valve embolization: Prosthesis moves upward or downward after final deployment, thereby losing contact with the aortic annulus Ectopic Valve Deployment: Prosthesis deployed in unintended location and unable to be explanted due to valve embolization or inability to deliver valve to intended location	immediate postoperative
Major Cardiac Structural Complications	Number of patients that had these events	before discharge, 30 days

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: West China Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital; People's Hospital of Xinjiang Uygur Autonomous Region; Fujian Medical University Union Hospital; Xinqiao Hospital of Chongqing; General Hospital of Ningxia Medical University; Chinese Academy of Medical Sciences, Fuwai Hospital; Fu Wai Hospital, Beijing, China; Yan'an Hospital of Kunming City; Henan Provincial Chest Hospital; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Dong'e People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Regurgitation; transcatheter aortic valve replacement; 3D simulation technology; DIGITAL
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: TAVR-AR-3D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No