Trials / Completed
CompletedNCT02274857
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures (REAFFIRM)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 350 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Standard PVI Ablation | Standard PVI procedure without FIRMap. |
| PROCEDURE | FIRM-Guided Procedure and PVI | FIRM-guided procedure followed by conventional ablation including PVI. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2018-11-10
- Completion
- 2018-11-10
- First posted
- 2014-10-24
- Last updated
- 2020-02-07
- Results posted
- 2020-02-07
Locations
18 sites across 3 countries: United States, Germany, Netherlands
Source: ClinicalTrials.gov record NCT02274857. Inclusion in this directory is not an endorsement.