CardiaMend and Amiodarone for the Prevention of POAF
NCT05641883 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-12-08
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.
Conditions
- POAF
- Atrial Fibrillation
Interventions
- COMBINATION_PRODUCT
-
CardiaMend with antiarrhythmic
Pericardial patch with antiarrhythmic drug (amiodarone) topically applied
Sponsors & Collaborators
-
Saint Alphonsus Regional Medical Center
lead OTHER
Principal Investigators
-
Robert Saeid Farivar, MD, PhD · Saint Alphonsus Regional Medical Center
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-01
- Primary Completion
- 2023-05-31
- Completion
- 2023-05-31
- FDA Device
- Yes
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