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:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT03064451
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years.
2. Patients who have signed the Patient Informed Consent Form (ICF)
3. Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of
1. persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days).
2. drug-resistant atrial fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate AF)
4. In AF at the time of the baseline CARTOFINDER™ Map (spontaneous)
5. Left Atrium (LA) must demonstrate sufficient electrical activity to allow for the identification of ablation targets.
6. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)
Exclusion Criteria:
1. Paroxysmal Atrial Fibrillation
2. Continuous AF \> 12 months (1-Year) (Longstanding Persistent AF) Subjects previously diagnosed as Long Standing Persistent (LSP) but have demonstrated the ability to maintain Normal Sinus Rhythm for \>30 days after cardioversion and have not been in AF greater than 1 year at the time of the procedure remain eligible for inclusion.
3. Previous ablation procedure for PsAF (defined as ablations involving more than only PV isolation)
4. Patients with a left atrial size \>55 mm (echocardiography, parasternal long axis view).
5. Inability to restore sinus rhythm for 30 seconds or longer in the opinion of the investigator.
6. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
7. Atrial arrhythmia patients with structural atrial disease such as a prior history of atriotomy from prior atrial surgery, presence of an atrial septal defect, and/or presence of an atrial septal closure patch.
8. History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor).
9. significant pulmonary disease, cardiac surgeries, unstable angina, uncontrolled heart failure, acute illness or systemic infection, or any other disease or malfunction that would preclude treatment in the opinion of the investigator.
10. Current enrollment in a study evaluating another device or drug.
11. A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
12. Any cardiac surgery within the past 60 days (2 months) (includes PCI)
13. Subjects that have ever undergone valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
14. Prior ICD or pacemaker implanted
15. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
16. Presence of a condition that precludes vascular access.
17. Subject has a contra-indication to the device under study per the IFU
18. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03064451
Study Brief:
Protocol Section:
NCT03064451