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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT01401361
Eligibility Criteria:
Inclusion Criteria:
* A signed written Informed Consent
* Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)
* If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on their medication for at least 3 months. If a subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.
* One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
* In good physical health
* 18 years of age or older
* Agree to comply with follow-up visits and evaluation
Exclusion Criteria:
* Prior typical atrial flutter ablation treatment
* Pregnancy
* Atypical flutter or scar flutter (non isthmus dependent)
* Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
* A recent myocardial infarction within 3 months of the intended procedure date
* Permanent coronary sinus pacing lead
* Clinically significant tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve.
* Evidence of intracardiac thrombus or a history of clotting disorders
* Participation in another investigational study
* Cardiac surgery within 1 month prior to the intended procedure date
* Allergy or contraindication to Heparin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01401361
Study Brief:
Protocol Section:
NCT01401361