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

Official title

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

Overview

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.

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.

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 controlla
• 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.

Primary outcome measures

• Access Site-Related Vascular Complications [Time frame: 30 days post-procedure]

Secondary outcome measures (4)

• Access Site-Related Bleeding Events [Time frame: 30 days post-procedure]
• Technical and Procedural Success of Vascular Closure [Time frame: Intra-procedure]
• Time to Access Site Haemostasis [Time frame: Intra-procedure]
• All-Cause and Cardiovascular Mortality [Time frame: 30 days post-procedure]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• University Heart Center Basel, University Hospital Basel — Basel

Identifiers

NCT: NCT07743697 · SEAL-TAVI trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗