N/A
N=73
Topera C-FIRM Registry
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02407249 ↗Enrolled (actual)
73
Serious AEs
4.1%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Acute Success — 53 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Success |
53 | — |
| PRIMARY Number of Participants With 12-Month Effectiveness |
34 | — |
| PRIMARY Number of Participants With Acute Safety Success |
56 | — |
| PRIMARY Number of Participants With 12-Month Safety Success |
45 | — |
Summary
This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard routine of the center.
Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.
Eligibility Criteria
Inclusion Criteria
- reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation
- attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication
Exclusion Criteria
- women who are pregnant
As this is a registry only data of patients will be included who have been treated according to the current AF guidelines and the daily routine of the center.
Data sourced from ClinicalTrials.gov (NCT02407249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.