CardiaMend and Amiodarone for the Prevention of POAF (NCT05641883) | Clinical Trial Compass
UnknownNot Applicable
CardiaMend and Amiodarone for the Prevention of POAF
30 participantsStarted 2023-01-01
Plain-language summary
The principal purpose of this investigator-initiated trial is to study the use of the CardiaMend device soaked in the anti-arrhythmic drug amiodarone, and how it may decrease the development of atrial fibrillation in patients that have undergone a coronary artery bypass surgery, or isolated valve surgery.
Who can participate
Age range21 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 21-85 years
* Able to provide written informed consent, understand and be willing to comply with study-related procedures.
* Scheduled to undergo open-chest cardiac surgery via complete median sternotomy for coronary artery bypass graft (CABG), or isolated valve repair/replacement.
* Inclusionary valve repair/replacement procedures with the primary reason for surgery inclusive of aortic valve repair/replacement or mitral valve repair/replacement.
* Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own.
* In sinus rhythm at the time of consultation and on a previous EKG, or no history of atrial fibrillation (note: continuous ECG monitoring for 48 hours is not required)
Exclusion Criteria:
* Unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with testing center or investigator.
* Any condition which could interfere with the subject's ability to comply with the study.
* Ongoing participation in an interventional clinical study or during the preceding 30 days.
* Female subjects who are pregnant, breastfeeding, were pregnant within the last three months or are planning a pregnancy during the course of the study.
* Active skin or deep infection at the site of implantat…