Aortic Valve StenosisSEAL-TAVINCT07743697
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
A study testing Single Suture-Based Vascular Closure Device and Extravascular Collagen Plug-Based Closure Device in people with Aortic Valve Stenosis and Postoperative Complications, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries
- What is being tested?
- Single Suture-Based Vascular Closure Device and Extravascular Collagen Plug-Based Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Heart Center Basel, University Hospital Basel
Basel, Canton of Basel-City, 4031
Max Wagener, MD, MSc, +41 61 265 44 44, max.wagener@usb.ch
Felix Mahfound, Prof., MD, MA, +41 61 556 58 10, Felix.Mahfoud@usb.ch
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- 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
- Medical subject headings
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Suture-Based Vascular Closure DeviceDevice
Also called Perclose ProGlide, Perclose ProStyle
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.
Extravascular Collagen Plug-Based Closure DeviceDevice
Also called Angio-Seal
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Suture Strategy | Active comparator | Single suture-based vascular closure device (VCD) pre-placed prior to sheath insertion. Receives: 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®) Receives: Device: Extravascular Collagen Plug-Based Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-procedure
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: Intra-procedure
All-Cause and Cardiovascular Mortality
Rates of all-cause mortality and cardiovascular mortality according to VARC-3 definitions.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 705 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, University Heart Center Freiburg - Bad Krozingen, University Hospital Giessen and Marburg, University College Hospital Galway
- Responsible party
- Sponsor
- Investigators
- Max Wagener, MD, MSc, Principal investigator, University Heart Center Basel, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743697
- Sponsor's protocol ID
- SEAL-TAVI trial
- Acronym
- SEAL-TAVI
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided