Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging

PHASE4CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

June 30, 2019

Study Completion Date

September 30, 2020

Conditions
Atrial Fibrillation
Interventions
PROCEDURE

Conventional AF ablation

"Conventional AF ablation will be carried out according to the standard procedure. Atrial anatomical MRI information will be integrated into the navigation system. Ablation procedure will be carried out with a Smart Touch® catheter (temperature 45 °C, 40W or 30W for anterior or posterior wall, respectively).~Both in first and re-do procedures, procedure endpoint will be electrical isolation of all pulmonary veins."

PROCEDURE

LGE-MRI guided AF ablation

"Post-processed LGE-MRI will be used to identify left atrial fibrotic patches and lesions surrounding pulmonary veins (re-do procedures). Both MRI atrial anatomical and fibrosis information will be integrated into the navigation system. Ablation procedures will be carried out with a SmartTouch® catheter (temperature 45°C, 40W or 30W for anterior or posterior wall, respectively).~* Procedural end-point for first ablation procedures will be isolation of all pulmonary veins, and encirclement and isolation of all atrial fibrotic areas.~* In re-do procedures, all left atrial fibrosis patches will be encircled and isolated and, for electrically non-isolated pulmonary veins, all anatomical gaps in lesions surrounding pulmonary veins (as identified in LGE-MRI) will be closed."

Trial Locations (2)

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08036

Hospial Clinic of Barcelona, Barcelona

All Listed Sponsors
collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

collaborator

University of Barcelona

OTHER

lead

Hospital Clinic of Barcelona

OTHER

NCT02698631 - Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging | Biotech Hunter | Biotech Hunter