NCT07398911

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

April 10, 2025

Last Update Submit

February 2, 2026

Conditions

Aortic Regurgitation

Keywords

Aortic Regurgitationtranscatheter aortic valve replacement3D simulation technologyDIGITAL

Outcome Measures

Primary Outcomes (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%

    12 months

Secondary Outcomes (16)

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

    30 days

  • Technical success

    immediate postoperative

  • All-cause mortality

    30 days,12 months

  • Device success

    30 days

  • Myocardial infarction

    before discharge, 30 days, 12 months

  • +11 more secondary outcomes

Study Arms (2)

Test group

EXPERIMENTAL

Using 3D simulation technique

Device: 3D simulation technique

Control group

NO INTERVENTION

Not using 3D simulation technique

Interventions

3D simulation techniqueDEVICE

using 3D simulation technique

Test group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 10, 2025

First Posted

February 10, 2026

Study Start

July 30, 2025

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

CN(1)