Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation (SUBSTRATE-HD)

Hospital Saint Joseph

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Routine substrate ablation without pulmonary vein Isolation; Procedure: Routine conventional ablation with pulmonary vein Isolation

Study type: Observational

Funder types: Other

Identifiers

NCT02093949

SUBSTRATE-HD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

152 participants in 2 patient groups

Studied

Description:

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

Treatment:

Procedure: Routine substrate ablation without pulmonary vein Isolation

Control

Description:

The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.

Treatment:

Procedure: Routine conventional ablation with pulmonary vein Isolation