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Enrolling by invitation NCT07398911

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

No phase Interventional Aortic Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D simulation technique.
Who it may be relevant to
Registry conditions: Aortic Regurgitation. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 3D simulation technique
    using 3D simulation technique

Primary outcome measures

  • Coaxial ratio of prosthetic aortic valve [Time frame: 12 months]
Secondary outcome measures (12)
  • All-cause death, Disabling stroke, Myocardial infarction, and Heart failure [Time frame: 30 days]
  • Technical success [Time frame: immediate postoperative]
  • All-cause mortality [Time frame: 30 days,12 months]
  • Device success [Time frame: 30 days]
  • Myocardial infarction [Time frame: before discharge, 30 days, 12 months]
  • Incidence of coronary obstruction [Time frame: before discharge]
  • CT imaging changes [Time frame: 12 months]
  • New York Heart Association Functional Classification [Time frame: before discharge, 30 days , 12 months]
  • Evaluation cardiac function by electrocardiography [Time frame: 30 days,12 months]
  • Evaluation cardiac function by electrocardiography [Time frame: 30 days,12 months]
  • Evaluation of bioprosthesis performance by echocardiography [Time frame: 30 days,12 months]
  • Evaluation of bioprosthesis performance by echocardiography [Time frame: 30 days,12 months]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xijing Hospital — Xi’an

Identifiers

NCT: NCT07398911 · TAVR-AR-3D

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗