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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT04216667
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or greater
4. In good general health as evidenced by medical history and diagnosed with symptomatic persistent AF or long-standing persistent AF.
1. Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 1 year.
2. Long-standing persistent AF will be defined as a sustained episode lasting more than 1 year and less than 10 years.
3. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
5. At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, ziopatch, telemetry, trans telephonic monitoring (TTM), or implantable device within last 10 years of enrollment in this investigation.
6. Patients undergoing first time procedure for AF.
Exclusion Criteria:
1. Patients with paroxysmal AF.
• Paroxysmal AF will be defined as a sustained episode lasting \< 7 days (either terminated spontaneously or with pharmacological or electrical cardioversion.
2. Reversible causes of AF.
3. Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
4. Patients with left atrial size ≥ 75 mm (2D echocardiography, parasternal long axis view)
5. Left atrial or LAA thrombus
6. Patients with severe valvular heart disease or after mitral valve replacement (bioprosthetic or mechanical).
7. Patients with a life expectancy ≤ 24 months
8. CHA2DS2Vasc score of 0 for men and CHA2DS2Vasc score of 1 for women.
9. Patients who are pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04216667
Study Brief:
Protocol Section:
NCT04216667