Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation

NACompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Atrial Fibrillation
Interventions
PROCEDURE

Pulmonary vein antrum isolation (PVAI)

In this group, only standard PVAI will be performed during the primary procedure. Three months later, a 2nd procedure will be performed in all subjects regardless of the recurrence of atrial arrhythmias. Subjects in whom pulmonary vein antrum remains isolated will enter follow-up; however, patients who have pulmonary vein-left atrium reconnection will undergo an re-isolation. Patients who have pulmonary vein antrum re-isolation are subject to a 3rd procedure 3 months later to check the status of pulmonary vein-left atrium connection. Patients will enter follow-up for long-term outcome only after permanent PVAI is confirmed by a repeat procedure.

PROCEDURE

PVAI plus left atrial posterior wall (LAPW) isolation

In this group, PVAI will be extended to the entire LAPW to achieve LAPW isolation during the primary ablation. Three months later, a 2nd procedure will be performed in all subjects regardless of the recurrence of atrial arrhythmias. Subjects in whom pulmonary vein antrum and LAPW remain isolated will enter follow-up; however, patients who have pulmonary vein antrum and/or LAPW reconnection will undergo a re-isolation. Patients who have pulmonary vein antrum and/or LAPW re-isolation are subject to a 3rd procedure three month later to check the presence of pulmonary vein antrum and/or LAPW re-connection. Patients will enter follow-up for long-term outcome only after PVAI and LAPW isolation are proven by a repeat procedure.

Trial Locations (1)

78705

Texas Cardiac Arrhythmia Institute, Austin

All Listed Sponsors
collaborator

Centro Cardiologico Monzino

OTHER

collaborator

Catholic University of the Sacred Heart

OTHER

collaborator

Capital Medical University

OTHER

lead

Texas Cardiac Arrhythmia Research Foundation

OTHER

NCT01660100 - Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation | Biotech Hunter | Biotech Hunter