Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
500 participants
INTERVENTIONAL
2026-04-30
2028-12-31
Brief Summary
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The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single arm study
Subjects who meet eligibility criteria will undergo AF ablation and left atrial appendage closure using the FARAPULSE PFA system and WATCHMAN FLX Pro or WATCHMAN FLX during one interventional case.
Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case
left atrial appendage closure
Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
FARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case.
Interventions
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Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case
left atrial appendage closure
Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
FARAPULSE PFA and WATCHMAN FLX Pro or WATCHMAN FLX in one interventional case.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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S2605
Identifier Type: -
Identifier Source: org_study_id
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