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Can a single stitch beat a double closure for TAVI patients?

NCT ID NCT07743697

Disease control Sponsor: University Hospital, Basel, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial compares two methods for closing the main artery in the leg after a TAVI procedure, which replaces a heart valve without open surgery. Half of the participants will have the artery closed with a single suture device, while the other half will receive a hybrid approach that adds a plug-based device. The goal is to see which method leads to fewer bleeding complications and faster recovery. Adults scheduled for transfemoral TAVI are eligible to join.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A single suture-based vascular closure device (Perclose ProGlide or Perclose ProStyle) compared with a hybrid approach adding a plug-based closure device.
What this could lead to
If a single suture works as well as the hybrid method, it could simplify the procedure, shorten recovery, and lower the risk of bleeding after TAVI.
What could go wrong
The trial is still testing the idea, and results may not show a clear benefit. There is also a risk that using only a suture could lead to more bleeding or vessel damage in some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 705 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Hemorrhage Postoperative Complications Vascular System Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve stenosis Hemorrhage Postoperative complications Vascular system injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Heart Center Basel, University Hospital Basel

    Basel, Canton of Basel-City, 4031, Switzerland

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