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Aortic RegurgitationDIGITALNCT07398911

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

A study testing 3D simulation technique in people with Aortic Regurgitation, run by Xijing Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aortic Regurgitation
What is being tested?
3D simulation technique
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
1 siteChina
Study dates
30 Jul 2025to 30 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Xijing Hospital

    Xi’an, Shanxi, 710032

Other trials in China

About this study

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.

Being tested
3D simulation technique
Keywords
Aortic Regurgitation, transcatheter aortic valve replacement, 3D simulation technology, DIGITAL
Medical subject headings
Aortic Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D simulation techniqueDevice

    using 3D simulation technique

Study groups in NCT07398911
Study groupRoleWhat they receive
Test groupExperimentalUsing 3D simulation technique
Receives: Device: 3D simulation technique
Control groupNo interventionNot using 3D simulation technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    Measured: 12 months

Secondary outcomes (16)

  1. All-cause death, Disabling stroke, Myocardial infarction, and Heart failure

    Number of patients that had any of these events

    Measured: 30 days

  2. 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

    Measured: immediate postoperative

  3. All-cause mortality

    Rate of all-cause mortality

    Measured: 30 days,12 months

  4. 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)

    Measured: 30 days

  5. Myocardial infarction

    Number of patients that had event

    Measured: before discharge, 30 days, 12 months

  6. Incidence of coronary obstruction

    Number of patients that had event

    Measured: before discharge

  7. CT imaging changes

    1. New aortic sinus volume formed after prosthetic valve implantation2) Low density leaflet thickening/leaflet thrombosis on prosthetic valve

    Measured: 12 months

  8. New York Heart Association Functional Classification

    Measured: before discharge, 30 days , 12 months

  9. Evaluation cardiac function by electrocardiography

    Left ventricular ejection fraction (%)

    Measured: 30 days,12 months

  10. Evaluation cardiac function by electrocardiography

    Left ventricular end diastolic diameter (mm)

    Measured: 30 days,12 months

  11. Evaluation of bioprosthesis performance by echocardiography

    Using the following measures:Aortic Valve Mean Gradient (cm2)

    Measured: 30 days,12 months

  12. Evaluation of bioprosthesis performance by echocardiography

    Using the following measures:Transaortic peak velocity

    Measured: 30 days,12 months

  13. Evaluation of bioprosthesis performance by echocardiography

    Using the following measures:Transaortic Central Regurgitation Severity

    Measured: 30 days,12 months

  14. Evaluation of bioprosthesis performance by echocardiography

    Using the following measures:Perivalvular Leak Severity

    Measured: 30 days,12 months

  15. 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

    Measured: immediate postoperative

  16. Major Cardiac Structural Complications

    Number of patients that had these events

    Measured: before discharge, 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start30 Jul 2025
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
354 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07398911
Sponsor's protocol ID
TAVR-AR-3D
Acronym
DIGITAL
Status last verified
Feb 2026
First submitted
10 Apr 2025
Last updated
10 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 3D simulation technique in people with Aortic Regurgitation, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coaxial ratio of prosthetic aortic valve (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07398911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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