N/A N=152

Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT02093949 ↗

Enrolled (actual)

152

Serious AEs

0.7%

Results posted

May 2017

Primary outcome: Primary: Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure — 95; 60 Percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Routine substrate ablation without pulmonary vein Isolation (Procedure); Routine conventional ablation with pulmonary vein Isolation (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital St. Joseph, Marseille, France
Primary completion: Dec 2014

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	—

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.

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)

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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.