European Carto® XP REgistry for Validating Specialized CFAE SOftware (EXPRESSO)
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About
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.
Full description
This was a prospective, multi-center, observational registry study evaluating CARTO® XP CFAE Software (CFAE Software) in subjects with chronic AF requiring CFAE-guided RFCA. Use of the CARTO® 3 System (including CFAE Software) was also allowed. The primary efficacy endpoint was the acute success rate of CFAE-guided radiofrequency catheter ablation (RFCA) using the CFAE Software. Acute success is defined as the subject achieving sinus rhythm at the end of the procedure without electrical or pharmaceutical cardioversion. Secondary endpoints consisted of measures of efficacy (example, performance of the CFAE Software) and of safety (example, number of procedure-related adverse events).
Enrollment
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Volunteers
Inclusion criteria
- Persistent or longstanding persistent AF
Exclusion criteria
- Previously underwent RF ablation for AF and patients with paroxysmal AF
Trial design
206 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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