AF Septal pacing

Phase 2

Completed

• Conditions: Atrial fibrilation; palpitations; 10007521

• Registration Number: NL-OMON45568
• Lead Sponsor: Medtronic B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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

* 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To regard pacing site stability, the number of electrodes that are<br /><br>successfully placed will be counted. For this purpose, the pacing threshold<br /><br>must be less than 10mA at a pulse width of 1ms and no ventricular capture<br /><br>should occur when stimulation occurs with twice the atrial pacing threshold.</p><br>