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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT05758805
Eligibility Criteria:
Inclusion Criteria:
1. Atrial fibrillation and, according to current guidelines, indication for radiofrequency ablation guided by electro-anatomical mapping with high-density mapping catheter and radiofrequency ablation by contact force ablation catheter.
2. Able to sign the consent form.
Exclusion Criteria:
1. LVEF \< 45%
2. Presence of thrombus in the left atrium
3. NYHA III/IV Class
4. Atrial diameter \> 50mm
5. Moderate or severe valve dysfunction
6. Implanted ICD/CRT-D
7. Life expectancy \< 1 year
8. Uncontrolled Hyperthyroidism
9. Hypertrophic or dilatative cardiomyopathy
10. Kidney failure (eGFR \< 30)
11. Body Mass Index (BMI)\> or = 35
12. Participation in another clinical trial in the past 3 months
13. Inability to express informed consent for the study
14. Patients with esophageal pathologies and a history of gastritis
15. Pregnancy (ascertained by performing the HCG test), breastfeeding, pregnancy planned during the study, or fertile female subjects who refused to use a highly effective contraceptive measure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05758805
Study Brief:
Protocol Section:
NCT05758805