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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT02699034
Eligibility Criteria:
Inclusion Criteria:
* First time indication for ablation for type I atrial flutter.
* Patients willing and able (mentally and physically capable per physician's discretion) to understand the investigational nature, potential risks and benefits of the study and able to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation
* Patients able to receive anticoagulation therapy to achieve adequate anticoagulation
Exclusion Criteria:
* Contraindication for MRI diagnostic exam
* A cardiac ablation or cardiac surgery within 180 days prior to enrollment
* Documented intracardiac thrombus, tumor, bleeding, clotting or other abnormality that precludes catheter introduction and placement
* Myocardial infarction within 60 days prior to enrollment
* Current unstable angina
* History of cerebrovascular event (within 180 days prior to enrollment)
* Patients with an ejection fraction less than or equal to 35% within 90 day prior to enrollment
* Permanent leads in or through the right atrium
* Clinically significant structural heart disease (including tricuspid valve regurgitation, tricuspid valve stenosis or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator
* Uncompensated congestive heart failure (NYHA Class III or IV)
* Arrhythmia is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
* Known sensitivity to heparin or warfarin
* Active or systemic infection
* Any other significant uncontrolled or unstable medical condition (including but not limited to hypertension and diabetes)
* contraindication for conventional ablation procedure know allergy against radiocontrast agents renal insufficiency with glomerular filtration rate \< 30ml/min/1,73m2
* Women who are pregnant or plan to become pregnant within the course of their participation in the investigation or who are breastfeeding
* Life expectancy of less than 12 months
* Patients with prosthetic valves
* Contraindicated for transfemoral venous access
* Older than 75 years
* Current enrollment in any other clinical investigation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02699034
Study Brief:
Protocol Section:
NCT02699034