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:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT05225532
Eligibility Criteria:
Inclusion Criteria:
* 1\. Documented spontaneous or tilt-induced syncope with at least 3 seconds of asystole due to sinus arrest or AVB, refractory to standard non-pharmacological treatment.
* 2\. High syncope burden (\> 1 syncope per year or \> 3 presyncopal events during preceding 12 months) or very severe syncope in the past, leading to injury.
* 3\. Significantly decreased quality of life due to syncope (\>20 points in QoL questionnaire dedicated to patients with syncope \[17\]).
* 4\. Standard ECG and 24hr ambulatory ECG recorded within one month before procedure.
* 5\. Positive baseline atropine test defined as at least 30% increase in sinus rate compared with baseline value.
* 6\. Obtained written informed consent.
* 7\. Age \> 16 years
Exclusion Criteria:
* 1\. Other possible and treatable causes of syncope such as orthostatic hypotension, IST, POTS, significant cardiac disease, cardiac arrhythmia or abnormalities of vertebrobasilar arteries
* 2\. History of stroke or TIA
* 3\. History of cardiac surgery
* 4\. Contraindications to ablation in the right or left atrium
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05225532
Study Brief:
Protocol Section:
NCT05225532