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.
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.
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.
Parallel
Single Suture-Based Vascular Closure Device
DeviceTransfemoral large-bore access site closure using a single pre-placed suture-based vascular closure device (Perclose ProGlide or Perclose ProStyle). The device is deployed at the beginning of the TAVI procedure prior to sheath insertion according to standard manufacturer instructions. Following procedure completion and main sheath removal, the single suture is tied down over a guide wire. Haemostasis is assessed immediately (Grade H0: dry/no bleeding, or Grade H1: minor oozing/bleeding controllable with manual compression). Final haemostasis is achieved via manual compression without additional plug adjuncts.
Extravascular Collagen Plug-Based Closure Device
DeviceAdjunctive deployment of an extravascular collagen plug-based vascular closure device (Angio-Seal 6F or 8F) following primary single-suture pre-placement. In patients achieving intra-operative Grade H0 (dry) or Grade H1 (minor oozing) haemostasis after primary suture tie-down, the Angio-Seal device is deployed over the retained safety guide wire into the common femoral artery access site to provide secondary extravascular mechanical sealing.
Access Site-Related Vascular Complications
Composite of major or minor access site-related vascular complications, defined and adjudicated according to the Valve Academic Research Consortium-3 (VARC-3) criteria.
Access Site-Related Bleeding Events
Incidence of access site-related bleeding events classified as Type 1 (minor), Type 2 (major), Type 3 (life-threatening), or Type 4 (fatal) according to VARC-3 criteria.
Technical and Procedural Success of Vascular Closure
Rate of successful access site haemostasis achieved with the primary allocated device strategy without requiring unplanned surgical intervention, covered stent implantation, or secondary bailout vascular closure device.
Time to Access Site Haemostasis
Time (in minutes) measured from main sheath removal to the complete cessation of access site bleeding (Grade H0).
All-Cause and Cardiovascular Mortality
Rates of all-cause mortality and cardiovascular mortality according to VARC-3 definitions.
Femoral Vascular Access Site Sequelae by Duplex Ultrasound
Rate of structural femoral artery abnormalities assessed via Doppler/Duplex ultrasound, including false aneurysm (pseudoaneurysm), arteriovenous fistula, vessel stenosis (\>50%), or acute vessel occlusion.
Post-Procedural Length of Stay
Number of days from the index TAVI procedure to discharge from the hospital.
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
University Hospital, Zürich
Collaborator
University Heart Center Freiburg - Bad Krozingen
Collaborator
University Hospital Giessen and Marburg
Collaborator
University Hospital Galway
Collaborator
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