CardiaMend + Amiodarone for Atrial Fibrillation

(CAMP POAF Trial)

Overseen By LaMonica Daniel, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: WakeMed Health and Hospitals

Must not be taking: Corticosteroids, Anti-inflammatories

Disqualifiers: Pregnancy, Atrial fibrillation, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

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?

Amiodarone has been shown to help maintain normal heart rhythm in patients with atrial fibrillation, especially when used before and after electrical treatments to reset the heart's rhythm. However, it can have side effects, so its use should be carefully considered for each patient. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{2 6 10 11 12}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CardiaMend and amiodarone during cardiac surgery to prevent postoperative atrial fibrillation

2 weeks

Continuous EKG monitoring until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including home monitoring if clinically indicated

2 weeks

Treatment Details

Interventions

• CardiaMend with the Addition of Amiodarone

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Benefit-risk assessment of current antiarrhythmic drug therapy of atrial fibrillation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Spontaneous conversion and maintenance of sinus rhythm by amiodarone in patients with heart failure and atrial fibrillation: observations from the veterans affairs congestive heart failure survival trial of antiarrhythmic therapy (CHF-STAT). The Department of Veterans Affairs CHF-STAT Investigators. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Pre- and post-treatment with amiodarone for elective electrical cardioversion of atrial fibrillation: a systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Early outcome of initiating amiodarone for atrial fibrillation in advanced heart failure. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Ranolazine enhances the efficacy of amiodarone for conversion of recent-onset atrial fibrillation. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

Amiodarone after unsuccessful direct-current cardioversion of persistent atrial fibrillation. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Dronedarone: a review of characteristics and clinical data. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Recurrence of arrhythmia following short-term oral AMIOdarone after CATheter ablation for atrial fibrillation: a double-blind, randomized, placebo-controlled study (AMIO-CAT trial). [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Dronedarone for atrial fibrillation: a new therapeutic agent. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Indications and limitations of class II and III antiarrhythmic drugs in atrial fibrillation. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Patterns of amiodarone use and outcomes in clinical practice for atrial fibrillation. [2020]