Not Yet RecruitingNot Applicable

Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)

Switzerland705 participantsStarted 2026-10-01

Plain-language summary

The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral access). The main questions it aims to answer are: Does using a single suture device lower the rate of access-related vascular complications compared to using a hybrid combination of a suture device and a plug-based closure device? How do the two closure strategies compare regarding bleeding complications, procedure time, and time to complete vessel sealing? Researchers will compare a single-suture closure strategy to a hybrid closure strategy (one suture plus one plug-based device) to see if using a single suture reduces vessel-related complications and improves patient safety after TAVI. Participants will: Undergo standard pre-procedure screening and TAVI via the main artery in the leg as part of routine medical care. Receive an initial single-suture placement before the large TAVI delivery system is inserted. Be evaluated after sheath removal for initial bleeding control; qualifying participants will then be randomly assigned (1:1) to either receive no additional device (single suture group) or receive a plug-based closure device (hybrid group). Have their heart and access site monitored during hospitalization, including laboratory checks and imaging prior to discharge. Complete a 72-hour safety and complication evaluation.

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: * Patient is at least 18 years of age at the time of screening. * Patient is scheduled to undergo elective transcatheter aortic valve implantation (TAVI) via transfemoral arterial access. * Patient is deemed suitable for transfemoral TAVI and large-bore vascular access closure by the local Heart Team. * Patient (or legally authorized representative) provides written informed consent prior to initiating any study-related procedures. * Patient is willing and able to comply with all specified study procedures, follow-up visits, and clinical evaluations. Exclusion Criteria: * Planned TAVI procedure via non-femoral arterial access (e.g., transapical, transaortic, subclavian/axillary, or carotid access). * Emergency or non-elective TAVI procedure. * Target main femoral artery vessel diameter, calcification, or tortuosity judged unsuitable for standard percutaneous large-bore vascular closure device deployment. * Known active, unresolved local or systemic infection at the planned vascular access site. * Known severe allergy or hypersensitivity to bovine tissue, collagen, or any component of the study closure devices (Perclose ProGlide/ProStyle or Angio-Seal) that cannot be adequately premedicated. * Severe bleeding diathesis, active major bleeding, or absolute contraindication to standard periprocedural anticoagulation or antiplatelet therapy. * Concurrent participation in another interventional clinical trial investigating cardiovascular devices or drugs that…

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.

1This trial is comparing two different ways to close the large blood vessel access site used during TAVI — a suture-only approach versus a combined closure strategy — so can you explain which method you currently use for me and whether participating in this trial might mean I receive a different closure technique than you'd normally choose?
2Since the trial is labeled Phase NA and hasn't started recruiting yet, what does that mean for how much safety and effectiveness data already exists for these two closure strategies, and is there enough evidence for you to feel confident about either approach for my specific situation?
3The trial is specifically focused on vascular complications, bleeding, and vessel injuries at the access site — how significant is that risk for me personally given my anatomy and overall health, and does that risk change depending on which closure method is used?
4Because this trial is not yet recruiting, is there a standard-of-care closure approach you would recommend for my TAVI procedure right now, and should we revisit this trial as an option once it opens?
5If I were eventually eligible and interested in this trial, what would my involvement actually look like — would it require extra visits, imaging, or monitoring compared to a standard TAVI procedure, and how might that fit with my current health and schedule?

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

Access Site-Related Vascular Complications

Timeframe: 30 days post-procedure

Trial details

NCT IDNCT07743697

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

Max Wagener, MD, MSc

+41 61 265 44 44 max.wagener@usb.ch

View on ClinicalTrials.gov More Aortic Valve Stenosis trials