N/A
Completed N=206
European Carto® XP REgistry for Validating Specialized CFAE SOftware
Source: ClinicalTrials.gov NCT00812916 ↗Enrolled (actual)
206
Serious AEs
6.3%
Results posted
Dec 2015
Primary outcomePrimary: Acute Success — 48.8 percentage achieving success
Summary
The purpose of this prospective observational study (registry) is to determine the acute success rate of a complex fractionated atrial electrogram (CFAE) guided ablation procedure using a dedicated software and to determine the functionality and performance of the CFAE software in patients with a type of persistent atrial fibrillation (AF) in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Success |
48.8 | — |
| SECONDARY Total Ablation Time |
61.4 | — |
| SECONDARY Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time |
27.7 | — |
| SECONDARY Total Radiofrequency (RF) Duration |
76.2 | — |
| SECONDARY Total Fluoroscopy Time |
43.3 | — |
| SECONDARY Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points |
33.5 | — |
Eligibility Criteria
Inclusion Criteria
- Persistent or longstanding persistent AF
Exclusion Criteria
- Previously underwent RF ablation for AF and patients with paroxysmal AF
Data sourced from ClinicalTrials.gov (NCT00812916). 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. Informational only — not medical advice.