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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT02257060
Eligibility Criteria:
Inclusion Criteria:
* At least one symptomatic episode of typical CTI dependent right atrial flutter documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device.
* Age 18 years or older.
Exclusion Criteria:
* Previous typical CTI dependent right atrial flutter ablation
* Uncontrolled heart failure or NYHA function class IV
* MI within the past 2 months
* Any cardiac surgery (i.e. CABG) within the past 2 months
* Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
* Awaiting cardiac transplantation or other cardiac surgery within the next 6 months
* Documented thromboembolic event (including TIA) within the past 12 months
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Active illness or active systemic infection or sepsis
* Unstable angina
* History of blood clotting or bleeding abnormalities
* Contraindication to anticoagulation (eg, heparin or warfarin)
* Life expectancy less than 6 months
* Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Presence of a condition that precludes vascular access
* Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
* Currently enrolled in another device, biologics, or drug study
* Contraindication for use of the investigational catheter, as indicated in the respective Instructions For Use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02257060
Study Brief:
Protocol Section:
NCT02257060