Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: Routine substrate ablation without pulmonary vein IsolationProcedure: 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
- 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).
- organized atrial activity (Atrial tachycardia or Flutter)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Studied Routine substrate ablation without pulmonary vein Isolation Between 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 Control Routine conventional ablation with pulmonary vein Isolation The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
- Primary Outcome Measures
Name Time Method Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure up to 240 min percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure
- Secondary Outcome Measures
Name Time Method Maximum Sustained AF Duration from first AF episode to baseline duration of the longest AF epiodes in months before ablation
% of Patients With Sinus Rhythm Conversion During the Procedure 180 min Radiofrequency Time (Min) up to 300 min Mean LA Volume baseline Left Atrial volume before ablation in ml
Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation 18 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 Procedure 18 months post ablation Adverse events
Spontaneous AF at the Beginning of the Procedure baseline 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