Clinical trial NCT02093949: Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation
Official title: Substrate Ablation Guided by Automatic High Density Mapping for the Treatment of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

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)

Primary outcomes:
measure: Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure
timeFrame: up to 240 min
Secondary outcomes:
measure: % of Patients With Sinus Rhythm Conversion During the Procedure
timeFrame: 180 min
measure: Radiofrequency Time (Min)
timeFrame: up to 300 min
measure: Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation
timeFrame: 18 Months post ablation
measure: Number of Patients With Major Adverse Events During and up to 18 Months After Procedure
timeFrame: 18 months post ablation
measure: Maximum Sustained AF Duration
timeFrame: from first AF episode to baseline
measure: Mean LA Volume
timeFrame: baseline
measure: Spontaneous AF at the Beginning of the Procedure
timeFrame: baseline
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Nice
country: France
facility: CHU
city: Paris
country: France
facility: Institut Mutualiste de Montsouris
Study officials:
affiliation: St Joseph hospital Marseille
name: Julien Seitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.