Trials / Completed
CompletedNCT02799043
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 269 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The hypothesis of this study was that Focal Impulse and Rotor Modulation (FIRM) guided procedures will eliminate the source of clinical arrhythmias in subjects with clinical indications for repeat AF ablation procedures. This study is a prospective, multicenter, randomized, controlled study to assess the safety and effectiveness of FIRM procedures followed by ablation including pulmonary vein isolation versus a standard conventional procedure including pulmonary vein isolation for the redo-treatment of persistent or paroxysmal atrial fibrillation after one failed previous pulmonary vein isolation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Standard PVI | Standard PVI procedure without FIRMap. |
| PROCEDURE | FIRM-Guided Procedure and PVI |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
- First posted
- 2016-06-14
- Last updated
- 2024-09-19
- Results posted
- 2024-09-19
Locations
24 sites across 4 countries: United States, Belgium, Germany, Netherlands
Source: ClinicalTrials.gov record NCT02799043. Inclusion in this directory is not an endorsement.