CardiaMend + Amiodarone for Atrial Fibrillation
(CAMP POAF Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a special patch called CardiaMend, combined with a medication called amiodarone, to prevent irregular heartbeats after certain heart surgeries. The patch repairs the heart's outer layer and delivers the medication directly to the heart. The study focuses on adults undergoing specific types of heart surgery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are already taking amiodarone, you cannot participate in this study.
What data supports the effectiveness of the drug combination CardiaMend and Amiodarone for treating atrial fibrillation?
Is the combination of CardiaMend and Amiodarone safe for humans?
Amiodarone is known to be effective for heart rhythm issues but has many side effects, which can limit its use. Dronedarone, a similar drug, was developed to have fewer side effects. There is no specific safety data available for CardiaMend combined with Amiodarone, but Amiodarone alone has a well-documented safety profile.16789
How does the drug CardiaMend + Amiodarone differ from other treatments for atrial fibrillation?
CardiaMend combined with Amiodarone may offer a unique approach by potentially enhancing the efficacy of Amiodarone, which is already a widely used drug for atrial fibrillation but has limitations like moderate effectiveness and delayed action. This combination could provide a more effective treatment option by addressing these limitations.26101112
Research Team
Judson B Williams, MD
Principal Investigator
WakeMed Health and Hospitals
Eligibility Criteria
This trial is for adults aged 20-85 undergoing heart surgery, specifically coronary artery bypass grafting or valve repair/replacement. They must be in normal heart rhythm at their visit and previous EKG, able to consent and follow the study plan. Excluded are those with implanted cardiac devices, on amiodarone already, high surgical risk, pregnant/breastfeeding women, immune-compromised individuals, ongoing participation in another clinical trial within the last month.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CardiaMend and amiodarone during cardiac surgery to prevent postoperative atrial fibrillation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including home monitoring if clinically indicated
Treatment Details
Interventions
- CardiaMend with the Addition of Amiodarone
Find a Clinic Near You
Who Is Running the Clinical Trial?
WakeMed Health and Hospitals
Lead Sponsor
Helios Cardio Inc.
Industry Sponsor
Helios Cardio Inc
Collaborator