cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Launched by BOSTON SCIENTIFIC CORPORATION · Nov 11, 2024

Keywords

ClinConnect Summary

The cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia trial, also known as the OPTION-A study, is investigating a combined treatment approach for patients with atrial fibrillation (AF). This trial focuses on using a specialized device called the FARAPULSE™ PFA system for AF ablation and the WATCHMAN device for closing a part of the heart called the left atrial appendage (LAA). This combined treatment is designed to help improve heart function and reduce the risk of blood clots during the same procedure.

To be eligible for this study, participants must be at least 18 years old and actively recommended for both the FARAPULSE™ PFA and WATCHMAN devices by their doctor. They should also be willing to participate in all parts of the study and provide informed consent. However, certain conditions may disqualify potential participants, such as having had previous AF procedures, specific heart conditions, or certain health issues like recent strokes or heart attacks. Those who join the study can expect to receive care according to their hospital's standards, with close monitoring throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN 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 clinical 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 ASD/PFO device.
• • 8. Subjects with a presence of a mechanical valve prosthesis in any position.
• • 9. Subjects with a myocardial infarction within 30 days prior to enrollment.
• • 10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 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), active conditions (e.g. infection, bleeding disorder, unstable angina) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present\*.
• • 14. Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.
• • 15. Subjects who are pregnant or planning to be pregnant.
• • 16. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
• • 17. 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.