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

NCT07743697 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: SEAL-TAVI trial
• Study Type: interventional
• Target: 705
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SEAL-TAVI; Transcatheter Aortic Valve Implantation; TAVI; Vascular Closure Device; Suture-Based Closure; Angio-Seal; ProGlide; ProStyle; Large-Bore Access; Vascular Complications; TAVR; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days post-procedure

Secondary Outcomes (4)

• Access Site-Related Bleeding Events

  30 days post-procedure

• Technical and Procedural Success of Vascular Closure

  Intra-procedure

• Time to Access Site Haemostasis

  Intra-procedure

• All-Cause and Cardiovascular Mortality

  30 days post-procedure

Other Outcomes (2)

• Femoral Vascular Access Site Sequelae by Duplex Ultrasound

  30 days post-procedure

• Post-Procedural Length of Stay

  Up to 30 days post-procedure

Study Arms (2)

Single-Suture Strategy

ACTIVE COMPARATOR

Single suture-based vascular closure device (VCD) pre-placed prior to sheath insertion.

Device: Single Suture-Based Vascular Closure Device

Hybrid Strategy (Suture + Plug)

EXPERIMENTAL

Single suture-based VCD combined with an extravascular plug-based VCD (Angio-Seal®)

Device: Extravascular Collagen Plug-Based Closure Device

Interventions

Extravascular Collagen Plug-Based Closure Device 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.

Also known as: Angio-Seal

Hybrid Strategy (Suture + Plug)

Single Suture-Based Vascular Closure Device 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.

Also known as: Perclose ProGlide, Perclose ProStyle

Single-Suture Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 could confound study endpoints.
• Patient is pregnant or breastfeeding.
• Patient belongs to a vulnerable population (e.g., individuals deprived of liberty, under guardianship, or unable to give informed consent).

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University Hospital, Zürich: collaborator
• University Heart Center Freiburg - Bad Krozingen: collaborator
• University Hospital Giessen and Marburg: collaborator
• University Hospital Galway: collaborator

Study Sites (1)

University Heart Center Basel, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Wounds and Injuries

Study Officials

• Max Wagener, MD, MSc

  University Heart Center Basel, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Wagener, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intra-operative vascular closure procedure, the operator (Investigator) and immediate interventional team (Care Providers) cannot be masked to device assignment during the TAVI procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

CH (1)