Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) (SEAL-TAVI)
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Details and patient eligibility
About
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.
Full 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.
Enrollment
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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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
705 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Max Wagener, MD, MSc
Data sourced from clinicaltrials.gov
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