CardiaMend + Amiodarone for Atrial Fibrillation

(CAMP POAF Trial)

Overseen By LaMonica Daniel, CCRP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: WakeMed Health and Hospitals

No Placebo Group

Prior Safety Data

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.

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

I am having surgery to fix or replace my aortic or mitral valve.

I am having heart surgery that may include fixing or replacing a valve or bypass surgery, but not just a procedure on the heart's left atrial appendage.

I am between 20 and 85 years old.

Exclusion Criteria

You have certain connective tissue diseases like Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, or Osteogenesis imperfecta.

I am currently taking steroids or other anti-inflammatory medications.

I have a history of irregular heartbeats.

Treatment Details

Interventions

• CardiaMend with the Addition of Amiodarone (Other)

Trial Overview The study tests if using CardiaMend along with Amiodarone can prevent atrial fibrillation after open-chest heart surgery like bypass grafts or valve repairs. Participants will receive both treatments and researchers will monitor if this combination helps reduce the occurrence of postoperative atrial fibrillation.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

All patients who are enrolled into the study will receive the treatment. This includes the CardiaMend which should be used according to the Instructions for Use with the exception that device hydration is performed with 3 ampules of amiodarone (150mg/3ml) instead of room temperature saline. For best results, the device should be fixed in place using a continuous or interrupted stitch (approximately 1 stitch per cm) to approximate the edge of the pericardial defect. The closed defect should not put pressure on the underlying structures. A non-absorbable monofilament suture is preferred such as 5-0 or 4-0 prolene. A small edge may be left open for drain placement and a small slit for LIMA in case of CABG

Who Is Running the Clinical Trial?

WakeMed Health and Hospitals

Lead Sponsor

Trials

8

Recruited

3,900+

Helios Cardio Inc.

Industry Sponsor

Trials

3

Recruited

170+

Helios Cardio Inc

Collaborator

Trials

2

Recruited

90+