Trials / Unknown
UnknownNCT05641883
CardiaMend and Amiodarone for the Prevention of POAF
A Prospective Pilot Study of the Combination of CardiaMend and Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Isolated Coronary Artery Bypass Grafting or Isolated Valve Surgery
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Saint Alphonsus Regional Medical Center · Academic / Other
- Sex
- All
- Age
- 21 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | CardiaMend with antiarrhythmic | Pericardial patch with antiarrhythmic drug (amiodarone) topically applied |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2023-05-31
- Completion
- 2023-05-31
- First posted
- 2022-12-08
- Last updated
- 2022-12-08
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05641883. Inclusion in this directory is not an endorsement.