NCT06743568 Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
| NCT ID | NCT06743568 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-10-15 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06743568 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06743568 currently recruiting?
Yes, NCT06743568 is actively recruiting participants. Contact the research team at ankang913@126.com for enrollment information.
Where is the NCT06743568 trial being conducted?
This trial is being conducted at Beijing, China, Shenzhen, China, Kunming, China.
Who is sponsoring the NCT06743568 clinical trial?
NCT06743568 is sponsored by China National Center for Cardiovascular Diseases. The trial plans to enroll 100 participants.