CompletedNot Applicable

Comparison of Different Vascular Closure Device in TAVI

Taiwan260 participantsStarted 2018-03-20

Plain-language summary

Femoral artery approach for transcatheter aortic valve implantation (TAVI) is an ideal approach site. However the closure for femoral artery after transfemoral TAVI is challenging. We aimed to compared the efficacy and safety of Angio-Seal + Proglide vs. Dual Proglide for femoral arteriotomy closure following TAVI

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>= 20 years old * Severe aortic stenosis and suitable candidate for transfemoral transcatheter aortic valve implantation Exclusion Criteria: * Age \< 20 years old * Severe aortic stenosis not suitable for transfemoral transcatheter aortic valve implantation * An initial plan for a surgical transfemoral cut-down approach

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vascular complication

Timeframe: during hospitalization for index procedure

Life threatening bleeding complication

Timeframe: within 24hrs after the index procedure

Major or minor bleeding complication without life threatening condition

Timeframe: within 24hrs after the index procedure

Trial details

NCT IDNCT05491070

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-13

View on ClinicalTrials.gov More Aortic Valve Stenosis trials