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Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Sponsor: University Hospital, Basel, Switzerland
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.
Official title: SEAL-TAVI - Suture vs combinEd Closure strAtegies in Large-bore Access After TAVI
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
705
Start Date
2026-10-01
Completion Date
2028-09
Last Updated
2026-08-04
Healthy Volunteers
No
Interventions
Single Suture-Based Vascular Closure Device
Transfemoral 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
Adjunctive 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.
Locations (1)
University Heart Center Basel, University Hospital Basel
Basel, Canton of Basel-City, Switzerland