At a glance
ClinicalIndex Comparison RecordN/ACompleted· 350 enrolled
Drug / intervention
Standard PVI Ablation +1 moreprocedure
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.
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
In Brief
A clinical study evaluating Standard PVI Ablation and FIRM-Guided Procedure and PVI for Persistent Atrial Fibrillation. Completed, enrolled 350 participants across 18 sites in 3 countries.
Detailed Summary
The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Atrial Fibrillation
CountriesGermany, Netherlands, United States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedOct 2014
Primary CompletionNov 2018
TodayJul 2026
First PostedOct 24, 2014
Enrollment StartOct 1, 2014
Primary CompletionNov 10, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.7 years ago
Interventions
Standard PVI Ablationprocedure
Standard PVI procedure without FIRMap.
FIRM-Guided Procedure and PVIprocedure
FIRM-guided procedure followed by conventional ablation including PVI.