Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07305194
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines \[15\] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction).
* Sinus rhythm at the time of implantation, with no documented episodes of atrial fibrillation prior to implantation, either in the medical history or in previous recordings (ECG, Holter, telemetry).
* Ability to be followed up for at least 24 months after implantation.
* Provision of written informed consent to participate in the study.
Exclusion Criteria:
* History of atrial fibrillation prior to implantation, either permanent or paroxysmal, documented on ECG, Holter, or telemetry.
* Prior pharmacological or interventional treatment for AF (e.g. antiarrhythmic drugs, catheter ablation).
* Inability to comply with long-term follow-up or non-adherence to follow-up visits.
* Contraindications to pacemaker lead placement at the selected sites.
* Participation in another study that could influence the results.
* Previous device implantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07305194
Study Brief:
Protocol Section:
NCT07305194