CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 269 enrolled
Drug / intervention
Standard PVI +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 4
  • ✓At least one documented episode of spontaneous persistent or paroxysmal AF in the last 3 months (by rhythm strip or ECG)
  • ✓One prior AF ablation (PVI-only, any technology) performed after January 1, 2013, but not within the last 3 months
  • ✓Left atrial diameter <6.0 cm (transthoracic or transesophageal echo) or <6.5 cm (CT or MRI) within 6 months prior to procedure
  • ✓Sustained spontaneous or induced AF (>5 minutes uninterrupted)
Key exclusion· 7
  • ✕Presence of clinically significant structural heart disease
  • ✕NYHA Class IV heart failure
  • ✕Ejection fraction <35%
  • ✕Prior AF ablation within the last 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02799043
NCT02799043N/ACompleted
CompareCT.gov

Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)

Abbott Medical Devices·interventional·Posted Jun 14, 2016·Updated Sep 19, 2024

In Brief

A clinical study evaluating Standard PVI and FIRM-Guided Procedure and PVI for Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation. Completed, enrolled 269 participants across 24 sites in 4 countries.

Detailed Summary

A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
CountriesBelgium, Germany, Netherlands, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2016
Enrollment StartJun 1, 2016
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.0 years ago

Interventions

Standard PVIprocedure

Standard PVI procedure without FIRMap.

FIRM-Guided Procedure and PVIprocedure