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One-Stop shop: new study tests dual procedure for AFib patients

NCT ID NCT07349121

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 6 times

Summary

This study is testing whether it is safe and effective to perform two heart procedures at the same time in people with atrial fibrillation (AF). The first procedure uses pulsed field ablation to correct the heart's rhythm, and the second closes off a small pouch in the heart to reduce stroke risk. About 500 participants across Europe, the Middle East, and Africa will be followed for 30 days to check for complications and treatment success.

What this could mean

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

Active substance
FARAPULSE Pulsed Field Ablation System and WATCHMAN FLX Pro or WATCHMAN FLX device
What this could lead to
If successful, this could show that combining two procedures in one session is safe and effective for managing atrial fibrillation and reducing stroke risk.
What could go wrong
This is an observational post-market study, not a randomized controlled trial, so results may not prove superiority. Risks include procedure-related serious adverse events like bleeding or device complications.

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 500 people

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

Started

Jun 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care. 2. Subjects who are willing and able to provide informed consent. 3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center. 4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law. Exclusion Criteria: 1. Subjects who underwent prior AF ablation procedure. 2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes. 3. Already surgically closed or otherwise excluded LAA. 4. The LAA anatomy does not accommodate a Closure Device. 5. Known or suspected atrial myxoma. 6. Presence of intracardiac thrombus\*. 7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) / patent foramen ovale (PFO) device. 8. Subjects with a presence of a mechanical valve prosthesis in any position. 9. Subjects with a myocardial infarction within 90 days prior to enrollment. 10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment. 11. Any planned electrical cardioversion within 30 days following LAAC device implant. 12. Subjects with a known inability to obtain vascular access. 13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present. 14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina). 15. Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation. 16. Subjects who are pregnant or planning to be pregnant. 17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion. 18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    5 sites in 5 countries. 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

  • AZORG - Hospital

    RECRUITING

    Aalst, Belgium

  • Clinique Pasteur - Toulouse

    RECRUITING

    Toulouse, France

  • IRCCS Policlinico San Donato

    RECRUITING

    San Donato Milanese, Italy

  • Klinicki bolnicki centar Zagreb

    RECRUITING

    Zagreb, Croatia

  • University Hospital of Salamanca

    NOT_YET_RECRUITING

    Salamanca, Spain

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