Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation

N/ACompletedNCT02093949

Hospital St. Joseph, Marseille, France152 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

Atrial Fibrillation

Interventions

Routine substrate ablation without pulmonary vein IsolationPROCEDURE

Routine conventional ablation with pulmonary vein IsolationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (3)

Hopital Saint Joseph

Marseille, France

CHU

Nice, France

Institut Mutualiste de Montsouris

Paris, France

Outcomes

Primary Outcomes

Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure

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

Time frame: up to 240 min

Secondary Outcomes

% of Patients With Sinus Rhythm Conversion During the Procedure

Time frame: 180 min

Radiofrequency Time (Min)

Time frame: up to 300 min

Percentage of Patients Free From Atrial Fibrillation 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.

Time frame: 18 Months post ablation

Number of Patients With Major Adverse Events During and up to 18 Months After Procedure

Adverse events

Time frame: 18 months post ablation

Maximum Sustained AF Duration

duration of the longest AF epiodes in months before ablation

Time frame: from first AF episode to baseline

Mean LA Volume

Left Atrial volume before ablation in ml

Time frame: baseline

Spontaneous AF at the Beginning of the Procedure

Spontaneous AF at the beginning of the procedure

Time frame: baseline

Data from ClinicalTrials.gov

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