N/A
Completed N=152
Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation
Source: ClinicalTrials.gov NCT02093949 ↗Enrolled (actual)
152
Serious AEs
0.7%
Results posted
May 2017
Primary outcomePrimary: Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure — 95; 60 Percentage of participants
Summary
To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure |
95; 60 | — |
| SECONDARY % of Patients With Sinus Rhythm Conversion During the Procedure |
71; 26 | — |
| SECONDARY Radiofrequency Time (Min) |
49.1; 84.6 | — |
| SECONDARY Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation |
89; 42 | — |
| SECONDARY Number of Patients With Major Adverse Events During and up to 18 Months After Procedure |
1; 1 | — |
| SECONDARY Maximum Sustained AF Duration |
12.2; 19.4 | — |
| SECONDARY Mean LA Volume |
168 | — |
| SECONDARY Spontaneous AF at the Beginning of the Procedure |
65 | — |
Eligibility Criteria
Inclusion Criteria
- Patient from 18 to 85, with AF* (paroxysmal, and persistent AF) and indication of AF ablation (including redos)* *In accordance with the recommendation of European Society of Cardiology (2010).
Exclusion Criteria
- organized atrial activity (Atrial tachycardia or Flutter)
Data sourced from ClinicalTrials.gov (NCT02093949). 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.