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Clinical Trial ยท NA ยท Recruiting

Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration

23 October 2026 NCT07523620 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
NA
Participants
ALL
Age Range
18 Years+

About This Trial

The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.

Who Can Join?

Inclusion Criteria: * Subject must provide written informed consent prior to any clinical investigation-related procedure. * 18 years of age or older, or the age of legal consent * CHA2DS2-VASc score of โ‰ฅ 3 for women and โ‰ฅ 2 for men * Able to stop anticoagulation by 90 days post index procedure * Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT * Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF * Documented symptomatic PAF or PersAF. Documentation requirements are as follows: Paroxysmal: * Physician's note indicating recurrent self-terminating AF with โ‰ฅ 2 episodes of PAF within the 12 months prior to enrollment AND * One electrocardiographically documented PAF episode within 12 months prior to enrollment. Persistent: Continuous AF sustained beyond 7 days and less than 1 year that…

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