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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02914860
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients, age ≥ 18 and ≤ 80 years.
2. Male or female, age ≥ 50 years in the healthy volunteers group
3. No heart pathology (for volunteers)
4. PAF, Pers AF and L-s Pers AF (ECG documented).
5. LVEF ≥ 50%
6. Able to provide written informed consent
7. Able to comply with the requirements of the study
Exclusion Criteria:
1. Previous AF ablation therapy
2. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
3. Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)
4. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
5. Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02914860
Study Brief:
Protocol Section:
NCT02914860