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Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation

Completed
Conditions
Atrial Fibrillation
Interventions
Procedure: Routine substrate ablation without pulmonary vein Isolation
Procedure: Routine conventional ablation with pulmonary vein Isolation
Registration Number
NCT02093949
Lead Sponsor
Hospital St. Joseph, Marseille, France
Brief 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.

Detailed Description

This study is observational :

This substrate ablation method is performed routinely in the centers involved in the study so, patients were not assigned by the investigators to undergo a specific procedure because of the study, in all cases patient would have beneficiate from this substrate mapping ablation method.

We assessed procedural and follow up outcomes of this subatrate ablation group and compared them with an historical control group undergoing conventional ablation.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
152
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
StudiedRoutine substrate ablation without pulmonary vein IsolationBetween September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
ControlRoutine conventional ablation with pulmonary vein IsolationThe validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
Primary Outcome Measures
NameTimeMethod
Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedureup to 240 min

percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure

Secondary Outcome Measures
NameTimeMethod
Maximum Sustained AF Durationfrom first AF episode to baseline

duration of the longest AF epiodes in months before ablation

% of Patients With Sinus Rhythm Conversion During the Procedure180 min
Radiofrequency Time (Min)up to 300 min
Mean LA Volumebaseline

Left Atrial volume before ablation in ml

Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation18 Months post ablation

% of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up.

Number of Patients With Major Adverse Events During and up to 18 Months After Procedure18 months post ablation

Adverse events

Spontaneous AF at the Beginning of the Procedurebaseline

Spontaneous AF at the beginning of the procedure

Trial Locations

Locations (3)

Hopital Saint Joseph

🇫🇷

Marseille, France

CHU

🇫🇷

Nice, France

Institut Mutualiste de Montsouris

🇫🇷

Paris, France

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