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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT05186220
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (\<40 bpm) or chronotropic incompetence in the exercise test).
* Absence of structural cardiopathy
Exclusion Criteria:
* Left ventricular ejection fraction \<50%
* Severe valvular disease
* Any type of cardiomyopathy such as hypertrophic cardiomyopathy
* Previous ischemic heart disease
* QRS interval \>130 ms
* Atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block Mobitz II, advanced atrioventricular block, complete atrioventricular block)
* Lifetime expectance \<12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05186220
Study Brief:
Protocol Section:
NCT05186220