← Back to Search


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
Screening 3 weeks
Treatment Varies
Follow Up through discharge, an average of 2 weeks
Awards & highlights

CAMP POAF Trial 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.

CAMP POAF Trial Eligibility Criteria

Inclusion Criteria

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

CAMP POAF Trial 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
Study treatment Arm

CAMP POAF 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
First Studied
Drug Approval Stage
How many patients have taken this drug
CardiaMend with the Addition of Amiodarone
Completed Phase 4

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility criteria for this trial?

"The criteria for admission into this medical trial requires that candidates be between 20 and 85 years old, with a diagnosis of atrial fibrillation. Approximately 30 individuals are being sought after."

Answered by AI

Are there vacancies available for participants in this scientific research?

"According to clinicaltrials.gov, this research is presently open for enrollment and was originally posted on January 20th of the current year with its last update occurring on the same day."

Answered by AI

How many participants have been enrolled in this medical experiment?

"Affirmative. Clinicaltrials.gov alludes to the fact that this trial is currently recruiting patients, which was first announced on January 20th 2023 and last updated on the same date. The investigation has a need for 30 participants from only one medical site."

Answered by AI

Are any individuals aged 45 and above being enrolled in this research?

"This study is open to members of the public aged between 20 and 85 years old. There are 11 trials catering for those under 18, and 496 for individuals over 65."

Answered by AI

Has this treatment received regulatory acceptance from the FDA?

"Due to this treatment being classified as Phase 4, which indicates it has already been approved, the safety is rated 3."

Answered by AI
~13 spots leftby May 2025