An interventional study of Single Suture-Based Vascular Closure Device and Extravascular Collagen Plug-Based Closure Device in Aortic Valve Stenosis, Postoperative Complications and Vascular System Injuries, sponsored by University Hospital, Basel, Switzerland. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 705 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single suture-based vascular closure device (VCD) pre-placed prior to sheath insertion.
Device: Single Suture-Based Vascular Closure Device
Single suture-based VCD combined with an extravascular plug-based VCD (Angio-Seal®)
Device: Extravascular Collagen Plug-Based 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.
Also known as: Perclose ProGlide, Perclose ProStyle
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
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.
Time frame: 30 days post-procedure
Access Site-Related Bleeding Events
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.
Time frame: 30 days post-procedure
Technical and Procedural Success of Vascular Closure
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.
Time frame: Intra-procedure
Time to Access Site Haemostasis
Time (in minutes) measured from main sheath removal to the complete cessation of access site bleeding (Grade H0).
Time frame: Intra-procedure
All-Cause and Cardiovascular Mortality
Rates of all-cause mortality and cardiovascular mortality according to VARC-3 definitions.
Time frame: 30 days post-procedure
Femoral Vascular Access Site Sequelae by Duplex Ultrasound
Rate of structural femoral artery abnormalities assessed via Doppler/Duplex ultrasound, including false aneurysm (pseudoaneurysm), arteriovenous fistula, vessel stenosis (\>50%), or acute vessel occlusion.
Time frame: 30 days post-procedure
Post-Procedural Length of Stay
Number of days from the index TAVI procedure to discharge from the hospital.
Time frame: Up to 30 days post-procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland →