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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
Timeline
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 belowSelect...
I am between 20 and 85 years old.
Select...
I am scheduled for open-heart surgery, such as bypass or valve repair.
Select...
I am having surgery to fix or replace my aortic or mitral valve.
CAMP POAF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through discharge, an average of 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through discharge, an average of 2 weeks
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 • NCT0012771234%
Hypotension
2%
death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Amiodarone
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CardiaMend with the Addition of Amiodarone
2023
Completed Phase 4
~30
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
Eligibility Criteria:
This trial includes the following eligibility 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.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 able to understand and willing to sign the consent form for the trial.I am currently taking amiodarone for heart rhythm problems.You have a device implanted in your heart to help with its function, such as a pacemaker or defibrillator.I am not pregnant, breastfeeding, have been pregnant in the last 3 months, or planning to become pregnant during the study.I am choosing to have a procedure to treat atrial fibrillation during my upcoming surgery.I am between 20 and 85 years old.I have a weakened immune system, but my diabetes is well-managed.I am on dialysis for end-stage kidney disease.I have a history of chronic wounds or problems with wound healing.I have a condition affecting the left side of my chest, including previous surgeries or deformities.I have had a procedure to treat irregular heartbeat.I do not have severe heart failure, very low heart pump function, or end-stage kidney disease.Your heart is beating normally when you visit the doctor's office, and you don't need to have continuous heart monitoring for 48 hours.I am scheduled for open-heart surgery, such as bypass or valve repair.My risk of dying within 30 days from surgery is over 5.5%.I have an infection where my implant will be placed.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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