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

February 2, 2026 updated by: Jian Yang, Xijing Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
354

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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%
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause death, Disabling stroke, Myocardial infarction, and Heart failure
Time Frame: 30 days
Number of patients that had any of these events
30 days
Technical success
Time Frame: immediate postoperative
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
Time Frame: 30 days,12 months
Rate of all-cause mortality
30 days,12 months
Device success
Time Frame: 30 days
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
Time Frame: before discharge, 30 days, 12 months
Number of patients that had event
before discharge, 30 days, 12 months
Incidence of coronary obstruction
Time Frame: before discharge
Number of patients that had event
before discharge
CT imaging changes
Time Frame: 12 months
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
Time Frame: before discharge, 30 days , 12 months
before discharge, 30 days , 12 months
Evaluation cardiac function by electrocardiography
Time Frame: 30 days,12 months
Left ventricular ejection fraction (%)
30 days,12 months
Evaluation cardiac function by electrocardiography
Time Frame: 30 days,12 months
Left ventricular end diastolic diameter (mm)
30 days,12 months
Evaluation of bioprosthesis performance by echocardiography
Time Frame: 30 days,12 months
Using the following measures:Aortic Valve Mean Gradient (cm2)
30 days,12 months
Evaluation of bioprosthesis performance by echocardiography
Time Frame: 30 days,12 months
Using the following measures:Transaortic peak velocity
30 days,12 months
Evaluation of bioprosthesis performance by echocardiography
Time Frame: 30 days,12 months
Using the following measures:Transaortic Central Regurgitation Severity
30 days,12 months
Evaluation of bioprosthesis performance by echocardiography
Time Frame: 30 days,12 months
Using the following measures:Perivalvular Leak Severity
30 days,12 months
Contents of evaluation: including valve displacement, valve embolism and ectopic valve deployment
Time Frame: immediate postoperative
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
Time Frame: before discharge, 30 days
Number of patients that had these events
before discharge, 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings