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Clinical Trials in China / NCT06743568
Recruiting Not applicable

Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation

NCT06743568 · tracked via the Priya Life Science China tracker
Sponsor
China National Center for Cardiovascular Diseases
Phase
Not applicable
Started
2024-10-15
Last updated
2024-12-20

Condition(s) studied

Aortic StenosisAscending Aortic Dilatation

Investigational drug(s) / intervention(s)

Transcatheter aortic valve replacement

Transcatheter aortic valve replacement: Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.

Study summary

This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Severe AS defined as an aortic valve area (AVA) of 1cm2 or less or an indexed AVA of 0.6 cm2/m2 or less; * Evaluation and selection for TAVR by the multidisciplinary heart team; * Maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (CT) scan * Anatomic suitability for a transfemoral vascular access; * Life expectancy of more than 12 months; * Age ≥65 years. Exclusion Criteria: * Pure aortic regurgitation; * History of surgical or transcatheter aortic valve replacement (valve in valve); * History of any aortic surgery; * Emergent surgery; * Patients who refused to be randomized or unable to complete regular follow-up.

Primary outcome measure(s)

  • Device success — Perioperative period
    (1) freedom from mortality; (2) successful access, delivery of the device, and retrieval of the delivery system; (3) correct positioning of a single prosthetic heart valve into the proper anatomical location; (4) freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; (5) intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
  • 30-day all-cause mortality — 30 days
    30-day all-cause mortality
  • 30-day adverse aortic events — 30 days
    Aortic-related death, aortic dissection, or aortic rupture.

Trial sites (3)

FacilityCityRegionStatus
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Beijing Beijing Municipality Recruiting
Fuwai Shenzhen Hospital Shenzhen Guangdong Not Yet Recruiting
Fuwai Yunnan Cardiovascular Hospital Kunming Yunnan Not Yet Recruiting

More China National Center for Cardiovascular Diseases trials in China

rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) Starting soon
Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease Recruiting
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death Active, not recruiting
The Chinese Hypertrophic Cardiomyopathy Study(CHCS) Recruiting
Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy Recruiting

Other trials for the same condition

Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA Enrolling by invitation
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis Enrolling by invitation
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial Recruiting
A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis Starting soon
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06743568 on ClinicalTrials.gov ↗ ← All trials in China