Atrial fibrilation palpitations
Conditions
Interventions
After the patient has undergone the ablation procedure, there is a waiting time
of half an hour. During this time we want to conduct the study. The patient
then already has monitor catheters in the
ablation
atrial fibrillation
pulmonary vein.
septal
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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 and able to cooperate with the study procedure. * Patient is willing and able to sign provide the Informed Consent for their participation in the study.
Exclusion criteria
Exclusion criteria: * Patients under 18 years or over 80 years old. * Women who are currently pregnant or have a positive pregnancy test. * Patients with an implantable cardiac device Patients who already underwent an AF septal ablation procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To regard pacing site stability, the number of electrodes that are successfully placed will be counted. For this purpose, the pacing threshold must be less than 10mA at a pulse width of 1ms and no ventricular capture should occur when stimulation occurs with twice the atrial pacing threshold. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 *The number of electrodes for which local capture is determined using pacing schemes with various pacing cycle lengths (PCL) for a duration of 10-30 seconds depending on when capture occurs, at the start of the scheme followed, if feasible, by slow pacing for 1.5 s at 180% AFCL, initiated by a single stimulus at 130% AFCL. *The spatial extend of capture (assessed from the atrial electrograms recorded from the multipolar right atrial catheter and the multipolar coronary sinus catheter) to obtain local atrial capture obtained with septal pacing of AF, will be assessed off-line after the study procedure. To assess whether AF termination can be obtained using a dual-stage septal pacing scheme, the surface ECG will be analyzed and the PCL and stimulation current used, will be noted to measure the number of subjects in which the pacing scheme successfully terminates the AF episode. | — |
Countries
Hungary, Netherlands
Outcome results
None listed