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3-Dimensional Simulation Guided Transcatheter Aortic Valve Replacement in Aortic Regurgitation(DIGITAL) | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

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

NCT07398911•Xijing Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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

•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);
+8 more criteria

Locations (1)

Xijing Hospital

Xi’an, Shanxi, China

Key Dates

Start Date

July 30, 2025

Primary Completion Date

May 30, 2026

Completion Date

May 30, 2026

Last Updated

February 10, 2026

Enrollment

354

ESTIMATED participants

Conditions

Aortic Regurgitation

Interventions

3D simulation technique

DEVICE

The ARTEMIS Data Collection Study

NCT07075861

Aortic Regurgitation Disease

View study

ACTIVE_NOT_RECRUITINGNA

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

NCT02732704

Aortic Regurgitation

View study

UNKNOWN

Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation

NCT04671758

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The ARTEMIS Data Collection Study

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation

Mitroflow DL Post Approval Study- North America

Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System

HAART Model 300 Annuloplasty Ring