One-Stop shop: new study tests dual procedure for AFib patients
NCT ID NCT07349121
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
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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
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
5 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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AZORG - Hospital
RECRUITINGAalst, Belgium
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Clinique Pasteur - Toulouse
RECRUITINGToulouse, France
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IRCCS Policlinico San Donato
RECRUITINGSan Donato Milanese, Italy
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Klinicki bolnicki centar Zagreb
RECRUITINGZagreb, Croatia
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University Hospital of Salamanca
NOT_YET_RECRUITINGSalamanca, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Can a breathing workout and walks help dialysis patients with irregular heartbeats?
- Zapping the ear: a new way to stop Post-Surgery heart rhythm problems?
- Can a new mapping and ablation system fix recurring atrial fibrillation?
- Can shedding pounds stop atrial fibrillation in its tracks?
- Pacemaker algorithm tuned to Heart's pumping may beat standard rate response