AF Septal Pacing (Clinical Investigation Plan)

Not Applicable

Completed

Brief Summary: The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum. The possibility to terminate atrial arrythmias will also be evaluated.

Detailed Description: The evidence of treating AF by pacing is limited, although these algorithms are of interest, since they appear to be safe and usually add little additional cost.

Using a computer model, a new dual-stage septal pacing has been developed.The proposed septal pacing algorithm could suppress AF reentries in a more robust way than classical single site rapid pacing. The feasibility of pacing both atria simultaneously from a single lead placed in the interatrial septum has been previously demonstrated clinically. The septal pacing concept has also been successfully tested in a computer model of AF and in a pig model . Experimental studies are now needed to determine whether similar termination mechanisms and efficacies can be observed in humans.

The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum

Recruitment & Eligibility

Inclusion Criteria

Patient referred to the center to undergo ablation of the pulmonary vein using radiofrequency (initial AF ablation, or redo procedure).
In case of paroxysmal AF the right atrium should be dilated as indicated by > 29 ml mm2 or the left atrium should be dilated as indicated by > 34 ml mm2.
Patient is willing and able to cooperate with the study procedure.
Patient is willing to provide the Informed Consent for their participation in the study.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Persistent and Paroxtmal AF Patients	Pulmonary vein ablation	Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation usinf a ring of electrodes positioned on the septum.

Primary Outcome Measures

Name	Time	Method
Number of Electrodes in a Stable Position	30 minutes	To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be \< 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.

Secondary Outcome Measures

Name	Time	Method
Localized Atrial Capture	30 minutes	To assess Localized Atrial Capture the following endpoints will be considered: - the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions
Termination of Atrial Tachyarrhythmia.	30 minutes	Termination of atrial tachyarrhythmia.

Locations (3): Gottsegen György Országos Kardiológiai Intézet
🇭🇺
Budapest, Hungary
Maastricht Universitair Medisch Centrum (MUMC)
🇳🇱
Maastricht, Netherlands
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands