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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT03759418
Eligibility Criteria:
Inclusion Criteria:
* All adult patient who had a heart procedure where an Atriclip device was deployed as the primary or secondary procedure between 3/2013-12/20/2016
* Patient is willing to undergo a trans esophageal echocardiogram, or if unable a CT angiogram
* If female, must be of non-childbearing potential or have a negative pregnancy test within 7 days prior to the procedure
* Patient is willing to sign an IRB approved Informed Consent
Exclusion Criteria:
* Patient did not have an Atriclip device as part of the surgical procedure between 3/2013 and 12/2016.
* Patient is unwilling or unable to undergo trans esophageal echocardiogram with general anesthesia or a CT angiogram
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03759418
Study Brief:
Protocol Section:
NCT03759418