Trials / Completed
CompletedNCT02386345
Topera E-FIRM Registry
EU Focal Impulse and Rotor Modulation Registry -Topera E-FIRM Registry-
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 299 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation. FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors. Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.
Detailed description
Prospective and retrospective enrollment is possible.
Conditions
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2017-05-31
- Completion
- 2018-07-31
- First posted
- 2015-03-11
- Last updated
- 2020-01-14
- Results posted
- 2019-10-15
Locations
9 sites across 2 countries: Germany, Netherlands
Source: ClinicalTrials.gov record NCT02386345. Inclusion in this directory is not an endorsement.