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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01385358
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years and ≤ 80
2. Symptomatic persistent AF (≥1≤5 years), refractory to at least 1 AAD and/or DCCV
3. Patient is legally competent and willing and able to sign informed consent form
4. Patient is willing and able to adhere to follow up visit protocols for the duration of the study
Exclusion Criteria:
1. Left ventricular ejection fraction \< 40%
2. Cardiovascular implantable electronic device (contraindicates MRI imaging)
3. Contraindication to anticoagulation
4. Thrombus in the LA despite anticoagulation
5. CVA within the previous 6 months
6. Previous thoracic \& cardiac surgery (including interventions for AF such as Cox-maze procedure)
7. Prior LA catheter ablation with the intention to treat AF
8. Prior AV nodal ablation
9. Patients actively participating in another research study will be not be permitted to enrol. Patients who have been involved with other research studies will be able to participate after a minimum period of 3 months after completion of prior study follow up.
10. Co-morbid condition that in opinion of investigator confers undue risk of GA or thoracoscopic surgery.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01385358
Study Brief:
Protocol Section:
NCT01385358