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

July 29, 2026 updated by: University Hospital, Basel, Switzerland

SEAL-TAVI - Suture vs combinEd Closure strAtegies in Large-bore Access After TAVI

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Large-bore arterial access (≥14 Fr) is a prerequisite for transfemoral transcatheter aortic valve implantation (TF-TAVI). While primary procedural success of TAVI has increased substantially, access site-related vascular and bleeding complications remain a major source of post-procedural morbidity, prolonged hospital stay, and mortality. Standard vascular closure strategies historically relied on dual suture-based vascular closure devices (VCDs). However, mechanical constraints such as subcutaneous suture entanglement, tissue tearing, or inappropriate knot closure may compromise the efficacy of dual-suture techniques.

The SEAL-TAVI trial is an investigator-initiated, prospective, multicenter randomized controlled trial designed to evaluate the safety and efficacy of a standardized single-suture pre-close strategy versus a hybrid strategy (single suture combined with an extravascular plug-based VCD) for primary access site management in an all-comer TF-TAVI population.

Procedural & Randomization Protocol

All enrolled patients undergo TAVI via transfemoral access according to established local clinical standards. Primary access closure follows a standardized intra-procedural common pathway:

Pre-Close Pathway: Under ultrasound guidance, femoral artery puncture is performed, and a single suture-based VCD is placed prior to insertion of the large-bore sheath.

Post-TAVI Hemostasis Assessment: Following completion of valve deployment and sheath removal, the pre-placed single suture is tightened, manual pressure is applied for 2 minutes, and systemic heparinization is antagonized.

Haemostasis Grading & Randomization: Primary access site bleeding is systematically graded prior to final closure selection:

H0: Optimal haemostasis; completely dry wound.

H1: Minor, non-pulsating arterial or venous bleeding.

H2: Pulsating arterial bleeding, manageable only by an additional VCD.

H3: No objective haemostasis / hosing bleeding.

Patients achieving adequate initial control (Grades H0 and H1) qualify for intra-procedural 1:1 randomization to either:

Single Suture Arm: Pre-placed single suture alone (no additional closure device).

Hybrid Arm: Pre-placed single suture plus secondary deployment of an extravascular plug-based VCD (Angio-Seal®).

Predefined Observation Arm Patients exhibiting primary closure failure or severe bleeding (Grades H2 and H3) prior to randomization, as well as those requiring non-protocol-mandated closure techniques, do not undergo randomization. To prevent selection bias and maintain real-world generalizability, these patients are prospectively tracked in a dedicated, parallel Predefined Observation Group.

Safety Oversight & Quality Assurance

Participant safety is monitored through multiple independent committees:

An Independent Data Safety Monitoring Board (DSMB) periodically evaluates safety metrics and unblinded accumulating data.

An Independent Clinical Event Adjudication Committee (CEC), blinded to treatment allocation, adjudicates all vascular, bleeding, and clinical adverse events according to Valve Academic Research Consortium 3 (VARC-3) consensus definitions.

Study Type

Interventional

Enrollment (Estimated)

705

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • University Heart Center Basel, University Hospital Basel
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single-Suture Strategy
Single suture-based vascular closure device (VCD) pre-placed prior to sheath insertion.
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.
Other Names:
  • Perclose ProGlide
  • Perclose ProStyle
Experimental: Hybrid Strategy (Suture + Plug)
Single suture-based VCD combined with an extravascular plug-based VCD (Angio-Seal®)
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.
Other Names:
  • Angio-Seal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access Site-Related Vascular Complications
Time Frame: 30 days post-procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access Site-Related Bleeding Events
Time Frame: 30 days post-procedure
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.
30 days post-procedure
Technical and Procedural Success of Vascular Closure
Time Frame: Intra-procedure
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.
Intra-procedure
Time to Access Site Haemostasis
Time Frame: Intra-procedure
Time (in minutes) measured from main sheath removal to the complete cessation of access site bleeding (Grade H0).
Intra-procedure
All-Cause and Cardiovascular Mortality
Time Frame: 30 days post-procedure
Rates of all-cause mortality and cardiovascular mortality according to VARC-3 definitions.
30 days post-procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femoral Vascular Access Site Sequelae by Duplex Ultrasound
Time Frame: 30 days post-procedure
Rate of structural femoral artery abnormalities assessed via Doppler/Duplex ultrasound, including false aneurysm (pseudoaneurysm), arteriovenous fistula, vessel stenosis (>50%), or acute vessel occlusion.
30 days post-procedure
Post-Procedural Length of Stay
Time Frame: Up to 30 days post-procedure
Number of days from the index TAVI procedure to discharge from the hospital.
Up to 30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Hospital, Zürich
University Heart Center Freiburg - Bad Krozingen
University Hospital Giessen and Marburg
University Hospital Galway

Investigators

  • Principal Investigator: Max Wagener, MD, MSc, University Heart Center Basel, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

July 29, 2026

First Submitted That Met QC Criteria

July 29, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEAL-TAVI trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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