AF Septal Pacing (Clinical Investigation Plan)

NACompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 26, 2018

Primary Completion Date

July 20, 2018

Study Completion Date

December 21, 2018

Conditions
Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation
Interventions
PROCEDURE

Pulmonary vein ablation

After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination.

Trial Locations (3)

1096

Gottsegen György Országos Kardiológiai Intézet, Budapest

6229 HX

Maastricht Universitair Medisch Centrum (MUMC), Maastricht

3435 CM

St. Antonius Ziekenhuis, Nieuwegein

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic BRC

INDUSTRY

NCT03242941 - AF Septal Pacing (Clinical Investigation Plan) | Biotech Hunter | Biotech Hunter