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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT07100834
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of recurrent symptomatic non-valvular paroxysmal AF (PAF);
2. Age 18 through 75 years-old on the day of enrollment;
3. Willing and capable of providing written informed consent;
4. Willing and capable of complying with all pre-, post- and follow-up testing andrequirements.
Exclusion Criteria:
1. AF secondary to electrolyte imbalance, thyroid disease, valvular disease, or reversible or non-cardiac cause;
2. Previous left atrium (LA) ablation or surgery;
3. Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration);
4. Severe dilatation of the LA (LAD \>50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE));
5. Pregnant or lactating (current or anticipated) at the time of catheter ablation;
6. Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study;
7. Any other conditions such as, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center that may lead to non-compliance with the protocol procedure or follow up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07100834
Study Brief:
Protocol Section:
NCT07100834