Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotom… (NCT05637970) | Clinical Trial Compass
CompletedNot Applicable
Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure
United States50 participantsStarted 2023-01-12
Plain-language summary
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that manual pressure will be held, shorter procedure time and less complications after the procedure.
Who can participate
Age range
18 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:
Delivery of a 14-16 French Transcatheter aortic valve replacement system
Exclusion Criteria:
* Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
* Use of an anticoagulant other than unfractionated heparin or bivalirudin during the procedure.
* Any use of glycoprotein inhibitors or cangrelor.
* Use of sheathless guides.
* Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
* Any active treatment with oral anticoagulants continued during course of procedure.
* Presence of arteriovenous dialysis fistula in the ipsilateral leg.
* Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band.
* Inability of the patient to personally consent for the study. (no surrogate consent)
* Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.
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.