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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment to prevent postoperative atrial fibrillation (POAF), a common heart rhythm problem after surgeries like bypass or valve repairs. The treatment combines CardiaMend, a cardiac support therapy, with amiodarone, an antiarrhythmic drug, during surgery. Individuals scheduled for open-chest heart surgery, such as coronary artery bypass grafting (CABG) or valve repair, and who maintain a normal heart rhythm, might be suitable candidates for this trial. As a Phase 4 trial, the research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for CardiaMend with the addition of amiodarone?

Research has shown that using CardiaMend with amiodarone is generally safe for patients. Amiodarone, a common medication for controlling heart rhythm, typically does not cause safety issues when combined with other heart treatments like blood thinners. However, one study found that some patients faced a higher risk of bleeding when amiodarone was combined with other treatments, though this may not directly relate to its use with CardiaMend.

Previous studies on similar combinations have not reported major safety problems. Researchers have explored this combination for its potential to reduce the risk of irregular heartbeats after heart surgery, which is encouraging. Overall, clinical experience and studies suggest that the treatment is generally well-tolerated. As with any medical treatment, discussing potential risks with a doctor is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for atrial fibrillation, which often focus on oral medications or surgical interventions, the combination of CardiaMend and amiodarone offers a unique approach. This treatment uses CardiaMend, a device enhanced with amiodarone, to potentially improve heart rhythm directly at the surgical site. Researchers are excited because this innovative delivery method could offer quicker and more targeted results by applying the antiarrhythmic medication exactly where it's needed. Additionally, this method might reduce systemic side effects commonly associated with oral amiodarone, making it a promising alternative in managing atrial fibrillation.

What evidence suggests that CardiaMend with the addition of amiodarone is effective for preventing postoperative atrial fibrillation?

Research has shown that amiodarone effectively prevents atrial fibrillation (AF), a common heart rhythm issue, after heart surgery. Previous studies found that amiodarone reduces the recurrence of AF by 20 to 50%. Specifically, 84% of patients using amiodarone remained free from AF after one year. In this trial, all participants will receive CardiaMend along with amiodarone, which researchers are studying as a method to prevent AF after surgeries such as heart bypass surgery. This combination aims to stabilize the heart post-surgery, potentially lowering the risk of AF. ^{2 6 7 8 9}

Who Is on the Research Team?

Judson B Williams, MD

Principal Investigator

WakeMed Health and Hospitals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06730828

NCT06730828 | Amiodarone-Infused CardiaMend Patches ... The purpose of this study is to determine the safety of a drug-device treatment for the prevention of postoperative atrial fibrillation following open heart ...

2. helioscardio.com helioscardio.com/news/helios-cardio-announces-first-patient-enrolled-in-fda-investigational-new-drug-ind-study-of-cardiamend-and-amiodarone-for-postoperative-atrial-fibrillation-prophylaxis

Helios Cardio Announces First Patient Enrolled in FDA ... Helios Cardio Announces First Patient Enrolled in FDA Investigational New Drug (IND) Study of CardiaMend™ and Amiodarone for Postoperative ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8756060/

Efficacy of amiodarone for the prevention of atrial fibrillation ... Altogether the results show that class I and III anti-arrhythmic drugs reduced AF recurrence after catheter ablation by 20 to 50%. Direct comparison between ...

4. ovid.com ovid.com/journals/helu/pdf/10.1016/j.hrtlng.2023.08.006~combination-prophylactic-amiodarone-with-beta-blockers

Combination prophylactic amiodarone with beta-blockers ... Metoprolol versus amiodarone in the prevention of atrial fibrillation after cardiac surgery: a randomized trial. Ann Intern. Med. 2010;153(11): ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25181386/

Efficacy of amiodarone in patients with atrial fibrillation with ... In amiodarone-treated patients (N = 1,107), freedom from recurrent atrial fibrillation was 84% and 45% at 1 and 5 years, respectively, with no differences ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37619317/

Combination prophylactic amiodarone with beta-blockers ... Combination prophylaxis with amiodarone and beta-blockers significantly lowered risks of POAF incidence in comparison to beta-blockers alone ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29274758/

Efficacy and Safety Outcomes of Direct Oral Anticoagulants ... Co-administration of DOACs and amiodarone, a dual P-gp/CYP3A4 inhibitor, does not seem to affect efficacy or safety outcomes in patients with atrial ...

8. jacc.org jacc.org/doi/10.1016/S0735-1097%2824%2902134-X

A SYSTEMATIC REVIEW AND META-ANALYSIS While many outcomes remained unaffected, combination notably increased intracranial and gastroenterological bleeding risks.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0147956323002157

Combination prophylactic amiodarone with beta-blockers ... Patients given combination amiodarone and beta-blockers had significantly lower risks of developing postoperative atrial fibrillation (POAF) in comparison to ...