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CardiaMend + Amiodarone for Atrial Fibrillation (CAMP POAF Trial)

Phase 4
Waitlist Available
Led By Judson B Williams, MD
Research Sponsored by WakeMed Health and Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject aged 20-85 years old
Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy including coronary artery bypass graft (CABG) or valve repair/replacement
Must not have
Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with, testing center or investigator
Female subjects who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through discharge, an average of 2 weeks
Awards & highlights

Summary

This trial looks at how CardiaMend and amiodarone can help prevent atrial fibrillation after heart surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Amiodarone may cause lung or liver problems, affect thyroid function or cause skin changes when exposed to sunlight. Side effects vary by individual and should be discussed with a healthcare provider.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 20 and 85 years old.
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I am scheduled for open-heart surgery, such as bypass or valve repair.
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I am having surgery to fix or replace my aortic or mitral valve.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am able to understand and willing to sign the consent form for the trial.
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I am not pregnant, breastfeeding, have been pregnant in the last 3 months, or planning to become pregnant during the study.
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I have an infection where my implant will be placed.
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I have a history of chronic wounds or problems with wound healing.
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I am currently taking steroids or other anti-inflammatory medications.
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I have a history of irregular heartbeats.
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I have had a procedure to treat irregular heartbeat.
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I am currently taking amiodarone for heart rhythm problems.
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I have a condition affecting the left side of my chest, including previous surgeries or deformities.
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I am on dialysis for end-stage kidney disease.
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I do not have severe heart failure, very low heart pump function, or end-stage kidney disease.
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My risk of dying within 30 days from surgery is over 5.5%.
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I am choosing to have a procedure to treat atrial fibrillation during my upcoming surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through discharge, an average of 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through discharge, an average of 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post Operative Atrial Fibrillation
Secondary outcome measures
Additional Hospital Time Required Due to Atrial Fibrillation/Flutter

Side effects data

From 2008 Phase 4 trial • 130 Patients • NCT00127712
34%
Hypotension
2%
death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Amiodarone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CardiaMend with the Addition of Amiodarone
2023
Completed Phase 4
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
CardiaMend supports cardiac function and healing, which is essential for patients recovering from cardiac surgery or managing chronic heart conditions. Amiodarone, an antiarrhythmic medication, stabilizes heart rhythm by prolonging the phase 3 of the cardiac action potential, helping to maintain sinus rhythm and prevent arrhythmias in AF patients. Other common treatments include beta blockers, which reduce heart rate and improve heart function, and anticoagulants, which prevent stroke by reducing the risk of blood clots. Understanding these mechanisms helps in selecting the most appropriate therapy based on individual health needs and treatment goals.

Find a Location

Who is running the clinical trial?

WakeMed Health and HospitalsLead Sponsor
5 Previous Clinical Trials
3,609 Total Patients Enrolled
Helios Cardio IncUNKNOWN
1 Previous Clinical Trials
63 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
63 Patients Enrolled for Atrial Fibrillation
Judson B Williams, MDPrincipal InvestigatorWakeMed Health and Hospitals

Media Library

CardiaMend with the Addition of Amiodarone (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05681182 — Phase 4
Atrial Fibrillation Research Study Groups: Single Arm
Atrial Fibrillation Clinical Trial 2023: CardiaMend with the Addition of Amiodarone Highlights & Side Effects. Trial Name: NCT05681182 — Phase 4
CardiaMend with the Addition of Amiodarone (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05681182 — Phase 4
~12 spots leftby Jul 2025
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