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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03929718
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of typical AFL confirmed by 12-lead ECG
* no documented AF on ECG, ambulatory monitor, pacemaker or ICD at any time
* scheduled to undergo catheter ablation of the CTI for treatment of AFL
* history of hypertension (HTN) or heart failure (HF) (reduced or preserved systolic function)
Exclusion Criteria:
* history of known AF episodes
* previous CTI or PVI ablation procedure
* other SVT mechanisms demonstrated (AVNRT, AVRT or accessory pathways)
* amiodarone usage within the past 3 months,
* unwillingness to participate or undergo insertable monitor implantation
* hyperkalemia (potassium \> 5.0 mEq/L)
* severe renal disease (Cr \>2.5 mg/dL \[men\], \>2.0 mg/dL \[women, GFR \< 30 mL/min/1.73 m2)
* life expectancy \< 18 months
* prior intolerance to treatment with an aldosterone antagonist
* current treatment with an aldosterone antagonist
* need for treatment with a class I or III AAD for another indication
* operative AFL (occurring within 30 days of surgery) that is expected to resolve
* presence of a cardiac rhythm device (pacemaker or ICD) capable of AF monitoring
* currently pregnant or nursing a child
* unwilling not to become pregnant and to use birth control while taking spironolactone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03929718
Study Brief:
Protocol Section:
NCT03929718