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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT05461612
Eligibility Criteria:
Inclusion Criteria:
* Have AF that persists (Persistent AF) for more than 7 days but less than 1 year; OR has required cardioversion for termination of AF in the past 6 months; AND is not due to a reversible cause.
* Be scheduled to undergo open-heart surgery
* Be able to adhere to follow-up requirements
Exclusion Criteria:
* Have active pericarditis or any systemic infection
* Have left atrial thrombus (including left atrial appendage)
* Have had a previous attempt to ablate atrial fibrillation
* Scheduled for left atrial exclusion or excision
* Have had previous surgical intervention in the left atrium, including left atrial appendage implant or exclusion
* Have NYHA Class IV heart failure
* Have long-standing persistent or permanent AF
* Long-standing persistent AF is defined as AF that persists for greater than 1 year
* Permanent AF is defined as AF where termination (sinus rhythm) is no longer pursued
* Have any condition that prevents placement of a catheter on the posterior wall of the left atrium
* History of Left Atrium (LA) infarction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05461612
Study Brief:
Protocol Section:
NCT05461612