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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01423994
Eligibility Criteria:
Inclusion Criteria:
-Patients are eligible if they have:
* \>1 syncopal spell within 1 year preceding enrollment, and
* bifascicular block on a 12-lead ECG, and
* Age \> 50 years and
* written informed consent. Syncope will be defined based on history using a standardized form.
Exclusion Criteria:
-Patients will be excluded if they have criteria related to study strategies, including:
1. previous pacemaker, ICD, or Implantable Loop Recorder in situ,
2. ACC/AHA/HRS Class I indication for permanent pacing or ICD implantation,
3. left ventricular ejection fraction \< 35% mandating ICD therapy,
4. contra-indication to a transvenous pacemaker such as artificial tricuspid valve or active sepsis.
-Patients will also be excluded if a potential competing cause of syncope poses a threat to life, such as:
5. hypertrophic cardiomyopathy,
6. documented sustained ventricular tachycardia or
7. inducible, sustained monomorphic ventricular tachycardia on EP study.
-They will be excluded if they have:
8. a history of myocardial infarction within 3 months prior to enrollment, and
9. a major chronic co-morbid medical condition that would preclude 24 months of follow-up.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01423994
Study Brief:
Protocol Section:
NCT01423994