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New heart procedure may reduce stroke risk without blood thinners

NCT ID NCT03088098

Disease control Sponsor: University of Zurich 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a procedure called left atrial appendage occlusion (LAAO) against standard blood-thinning medications in 81 people with atrial fibrillation who were also getting a new heart valve (TAVI). The goal was to see if LAAO could prevent strokes and bleeding better than meds alone. Results will help doctors choose the best treatment for these high-risk 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

81 people

The number who actually took part.

Started

May 2016

Finished

Feb 2025

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: * Severe aortic valve stenosis with an indication for aortic valve replacement (e.g., symptomatic patient, decreased left ventricular (LV) function) * Suitable anatomy for transfemoral TAVI with the Portico Transcatheter Aortic Valve System (ileofemoral arterial diameter, annulus-coronary distance, annulus diameter) * No mobile thrombus in the LA or LAA precluding LAAO * Atrial fibrillation with a CHA2DS2-Vasc-Score \>=1. No limitation regarding the nature of atrial fibrillation (paroxysmal, permanent, persistent) Exclusion Criteria: * Pregnancy * Known intolerance to aspirin, heparin, contrast media or clinically manifest nickel allergy * Inability to provide informed consent * Mechanical heart valve or other indication for oral anticoagulation (i.e. recent pulmonary embolism) * Contraindication for oral anticoagulation * Currently participating in another trial

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis atrial fibrillation

As listed by the trial registrant

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

Aortic stenosis Atrial fibrillation

Contacts and locations

Locations

  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.