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Tests treatment safety and results for Aortic Stenosis
Official title Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
ClinicalTrials.gov ID: NCT06743568
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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;
You likely can't join if
- 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 assigned by chance or unable to complete regular follow-up.
See the full eligibility 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.
- 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 assigned by chance or unable to complete regular follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shenzhen, Guangdong, China
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shenzhen, Guangdong, China; Kunming, Yunnan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.