At a glance
ClinicalIndex Comparison RecordN/ACompleted· 180 enrolled
Drug / intervention
FARAPULSE Pulsed Field Ablation Systemdevice
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.
The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
In Brief
A clinical study evaluating FARAPULSE Pulsed Field Ablation System for Paroxysmal Atrial Fibrillation. Completed, enrolled 180 participants across 13 sites in 6 countries.
Detailed Summary
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesBelgium, Czechia, Denmark, Germany, Netherlands, Switzerland
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartDec 2021
Primary CompletionOct 2023
Study CompletionOct 2023
TodayJul 2026
First PostedOct 11, 2021
Enrollment StartDec 21, 2021
Primary CompletionOct 12, 2023
Study CompletionOct 19, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.7 years ago
Interventions
FARAPULSE Pulsed Field Ablation Systemdevice
A pulmonary vein isolation will be performed using catheter ablation