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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT02954666
Eligibility Criteria:
Inclusion Criteria:
Candidates must meet all of the inclusion criteria required for inclusion in one of the two groups (summarized in Table 2). All of the patients need to have a positive P wave of \> 0.5 mm in lead 2. Patients must have had ≥ 1 syncope during the 6 months preceding enrollment and ≥ 2 syncopes in their lifetime except if the last syncope was complicated by an injury or an accident, in which case further waiting for CardNM may be less desirable. Patients \< 18 years must have least 3 syncopes with an interval exceeding 1 month unless 1 syncope was complicated by an injury or an accident.
If a significant rate drop (\> 15%) is noted during head-up tilt test (HUT), either isolated or combined with vasoplegia, and associated with syncope or severe presyncope, patients will be eligible for inclusion in group A. If the HUT is negative and a pause \> 3 seconds has been documented, patients will be assigned to group B. If both conditions are present, patients will be eligible for inclusion in either group but will be preferentially assigned to group A.
Exclusion Criteria:
Candidates will be excluded if ANY of the following criteria apply (detailed in Table 3):
* \< 14 years of age;
* Inability to provide consent;
* Chronotropic negative medications (excepted in patients with a previous history of atrial fibrillation);
* 4 g amiodarone intake during the 2 months preceding enrollment;
* Alternating right bundle branch block (RBBB) and left bundle branch block (LBBB), HV interval \> 70 ms;
* LBBB, bifascicular block (RBBB + left anterior hemiblock \[LAHB\], RBBB + left posterior hemiblock \[LPHB\]);
* PR interval permanently \> 240 ms;
* Permanent AF, PAF or electrical cardioversion during the last 6 months;
* Valvular or subvalvular aortic stenosis, mitral stenosis;
* Any unstable medical condition, life expectancy \< 12 months;
* Syncopes due a non-cardiac disease (excepted NMS) or advanced neuropathy;
* Current pregnancy;
* glaucoma.
Patients with transient atrioventricular conduction disturbances and normal atrioventricular conduction during an exercise test and normal QRS complexes are eligible for this study.
Patients with a high risk of bleeding are eligible, but clopidogrel (75 mg daily, 1 month of treatment) will then be preferred to oral anticoagulants.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT02954666
Study Brief:
Protocol Section:
NCT02954666