3D US Guided Femoral Artery Access for TAVI (NCT04691245) | Clinical Trial Compass
UnknownNot Applicable
3D US Guided Femoral Artery Access for TAVI
Netherlands104 participantsStarted 2021-02
Plain-language summary
Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.
Who can participate
Age range
18 Years – 85 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:
* Adult age (\>18 years)
* Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery
* Written Informed consent
Exclusion Criteria:
* Unable to obtain informed consent
* Vascular access via alternative approach (radial/subclavian) or surgical cutdown
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.