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

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.

Conditions

• Aortic Valve Stenosis
• Postoperative Complications
• Vascular System Injuries
• Hemorrhage

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• University Hospital, Zürich

  collaborator OTHER

• University Heart Center Freiburg - Bad Krozingen

  collaborator OTHER

• University Hospital Giessen and Marburg

  collaborator OTHER

• University Hospital Galway

  collaborator UNKNOWN

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Max Wagener, MD, MSc · University Heart Center Basel, University Hospital Basel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2028-09-30

Completion

2028-09-30

FDA Device

Yes

Countries

• Switzerland

Study Locations