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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
442
PFA using Irreversible Electroporation (IRE) Ablation System
St. Bernard's Heart and Vascular Center
Jonesboro, Arkansas, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Incidence of early onset primary adverse events (PAEs)
Time frame: within seven (7) days of an ablation procedure
Freedom from documented atrial tachyarrhythmia episodes
Time frame: effectiveness evaluation period (Day 91-Day 365)
Freedom from acute procedural failure
Time frame: during ablation procedure
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Mount Sinai Hospital
New York, New York, United States
NOT_YET_RECRUITINGMontefiore Medical Center
New York, New York, United States
RECRUITINGTexas Cardiac Arrhythmia Institute/Research Foundation
Austin, Texas, United States
RECRUITING