At a glance
ClinicalIndex Comparison RecordN/ACompleted· 362 enrolled
Drug / intervention
Pulse Field Ablationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (AdmIRE)
In Brief
A clinical study evaluating Pulse Field Ablation for Atrial Fibrillation. Completed, enrolled 362 participants across 30 sites.
Detailed Summary
To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartApr 2022
Primary CompletionDec 2023
TodayJul 2026
First PostedMar 24, 2022
Enrollment StartApr 18, 2022
Primary CompletionDec 11, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.3 years ago
Interventions
Pulse Field Ablationdevice
PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator