Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF

Recruiting N/A Interventional Study
Atrial Fibrillation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
442 (estimated)
Sponsor
Massachusetts General Hospital · Other
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About This Trial

The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telem…
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