Post Operative Atrial FibrillationPhase 4CAMP POAFNCT05681182
Prevention of Post-OP AFib Using Combination of CardiaMend and Amiodarone
A Phase 4 study testing CardiaMend with the Addition of Amiodarone in people with Post Operative Atrial Fibrillation, run by WakeMed Health and Hospitals at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing isolated cardiac arterial bypass grafting (CABG) or valve surgery. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Post Operative Atrial Fibrillation
- What is being tested?
- CardiaMend with the Addition of Amiodarone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 6 Feb 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged 20-85 years old.
- Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures.
- Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes:
- Coronary artery bypass graft (CABG) or valve repair/replacement, or
- Inclusionary valve repair/replacement procedures for the primary reason for surgery include: aortic valve repair/replacement, mitral valve repair/replacement.
- Note: Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own.
- In sinus rhythm at the time of office visit and prior EKG (note: continuous EKG monitoring for 48 hours is not required).
Who cannot join
- 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.
- Any condition which could interfere with the subject's ability to comply with the study.
- Ongoing participation in an interventional clinical study or during the preceding 30 days.
- 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.
- Active skin or deep infection at the site of implantation.
- History of chronic wounds or wound-healing disorders.
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- Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
- Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion).
- Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
- The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers).
- Known history of atrial fibrillation or paroxysmal atrial fibrillation.
- History of ablation for atrial fibrillation.
- Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
- Disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
- Subjects with end-stage chronic-renal disease / dialysis.
- Subjects with heart failure (BNP>1000), low ejection fraction (<35%), end stage renal disease (on dialysis or creatinine >1.8).
- STS risk >5.5% for 30 day mortality.
- Patients electing to receive an ablative procedure for atrial fibrillation during the index operation.
Trial locations and contacts
1 site in 1 country.
United States1 site
WakeMed Health and Hospitals
Raleigh, North Carolina, 27610
About this study
Official title: A Prospective Pilot Study of the Combination of CardiaMend and Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Isolated Cardiac Arterial Bypass Grafting or Isolated Valve Surgery (CAMP POAF)
The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing isolated cardiac arterial bypass grafting (CABG) or valve surgery.
Read the detailed description
This study will investigate CardiaMend, an FDA cleared (K210331) pericardial reconstruction matrix used in combination with amiodarone, an FDA approved antiarrhythmic drug, as a prevention of POAF.
This is a single-center, prospective, pilot study, enrolling adult subjects undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy.
CardiaMend 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.
Patients will have continuous EKG until discharge. If clinically indicated, patients will receive a monitor for home monitoring per standard of care.
- Conditions
- Post Operative Atrial Fibrillation
- Being tested
- CardiaMend with the Addition of Amiodarone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiaMend with the Addition of AmiodaroneCombination product
The CardiaMend patch will be saturated with Amiodarone prior to being sutured into place.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | 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 Receives: Combination Product: CardiaMend with the Addition of Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Atrial Fibrillation
The patient will have continuous ECG monitoring until discharge to evaluate for any evidence of atrial fibrillation or atrial flutter which lasts longer than one hour or if less than one hour, requires medical or procedural intervention
Measured: On Average of one Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start20 Jan 2023
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post Operative Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- WakeMed Health and Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Helios Cardio Inc.
- Responsible party
- Principal investigator, Judson Williams, WakeMed Health and Hospitals
- Investigators
- Judson B Williams, MD, Principal investigator, WakeMed Health and Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681182
- Sponsor's protocol ID
- 1937514
- Acronym
- CAMP POAF
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2022
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Rego A, Cheung PC, Harris WJ, Brady KM, Newman J, Still R. Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions. J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5.
PubMed 30876459Echahidi N, Pibarot P, O'Hara G, Mathieu P. Mechanisms, prevention, and treatment of atrial fibrillation after cardiac surgery. J Am Coll Cardiol. 2008 Feb 26;51(8):793-801. doi: 10.1016/j.jacc.2007.10.043.
PubMed 18294562Lowres N, Mulcahy G, Jin K, Gallagher R, Neubeck L, Freedman B. Incidence of postoperative atrial fibrillation recurrence in patients discharged in sinus rhythm after cardiac surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2018 Mar 1;26(3):504-511. doi: 10.1093/icvts/ivx348.
PubMed 29161419Habbab LM, Chu FV. Intrapericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation. J Card Surg. 2016 Apr;31(4):253-8. doi: 10.1111/jocs.12700. Epub 2016 Feb 2.
PubMed 26833498Camm AJ. Safety considerations in the pharmacological management of atrial fibrillation. Int J Cardiol. 2008 Jul 21;127(3):299-306. doi: 10.1016/j.ijcard.2007.11.006. Epub 2008 Jan 8.
PubMed 18191470Frendl G, Sodickson AC, Chung MK, Waldo AL, Gersh BJ, Tisdale JE, Calkins H, Aranki S, Kaneko T, Cassivi S, Smith SC Jr, Darbar D, Wee JO, Waddell TK, Amar D, Adler D; American Association for Thoracic Surgery. 2014 AATS guidelines for the prevention and management of perioperative atrial fibrillation and flutter for thoracic surgical procedures. J Thorac Cardiovasc Surg. 2014 Sep;148(3):e153-93. doi: 10.1016/j.jtcvs.2014.06.036. Epub 2014 Jun 30. No abstract available.
PubMed 25129609Beau J, Kulik A. Topical amiodarone to prevent postoperative atrial fibrillation: Need for further study. J Thorac Cardiovasc Surg. 2016 Feb;151(2):600. doi: 10.1016/j.jtcvs.2015.10.007. No abstract available.
PubMed 26806512
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of the Combination of CardiaMend and Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Isolated Cardiac Arterial Bypass Grafting or Isolated Valve Surgery (CAMP POAF)
- ClinicalTrials.gov ID
- NCT05681182
- Acronym / sponsor ID
- CAMP POAF / 1937514
- Conditions
- Post Operative Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- WakeMed Health and HospitalsUniversity, hospital or other
- Collaborators
- Helios Cardio Inc.
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing isolated cardiac arterial bypass grafting (CABG) or valve surgery.
Detailed description
This study will investigate CardiaMend, an FDA cleared (K210331) pericardial reconstruction matrix used in combination with amiodarone, an FDA approved antiarrhythmic drug, as a prevention of POAF.
This is a single-center, prospective, pilot study, enrolling adult subjects undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy.
CardiaMend 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.
Patients will have continuous EKG until discharge. If clinically indicated, patients will receive a monitor for home monitoring per standard of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Combination Product: CardiaMend with the Addition of AmiodaroneAll 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 may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject aged 20-85 years old.
- Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures.
- Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes:
- In sinus rhythm at the time of office visit and prior EKG (note: continuous EKG monitoring for 48 hours is not required).
Key exclusion criteria (18 listed)
- 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.
- Any condition which could interfere with the subject's ability to comply with the study.
- Ongoing participation in an interventional clinical study or during the preceding 30 days.
- 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.
- Active skin or deep infection at the site of implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardiaMend with the Addition of AmiodaroneThe CardiaMend patch will be saturated with Amiodarone prior to being sutured into place. | Combination product | Single Arm |
Primary outcome
Post Operative Atrial Fibrillation
Time frame: On Average of one Week
The patient will have continuous ECG monitoring until discharge to evaluate for any evidence of atrial fibrillation or atrial flutter which lasts longer than one hour or if less than one hour, requires medical or procedural intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30876459Rego A, Cheung PC, Harris WJ, Brady KM, Newman J, Still R. Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions. J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5.
- Results publication: PubMed 18294562Echahidi N, Pibarot P, O'Hara G, Mathieu P. Mechanisms, prevention, and treatment of atrial fibrillation after cardiac surgery. J Am Coll Cardiol. 2008 Feb 26;51(8):793-801. doi: 10.1016/j.jacc.2007.10.043.
- Results publication: PubMed 29161419Lowres N, Mulcahy G, Jin K, Gallagher R, Neubeck L, Freedman B. Incidence of postoperative atrial fibrillation recurrence in patients discharged in sinus rhythm after cardiac surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2018 Mar 1;26(3):504-511. doi: 10.1093/icvts/ivx348.
- Results publication: PubMed 26833498Habbab LM, Chu FV. Intrapericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation. J Card Surg. 2016 Apr;31(4):253-8. doi: 10.1111/jocs.12700. Epub 2016 Feb 2.
- Results publication: PubMed 18191470Camm AJ. Safety considerations in the pharmacological management of atrial fibrillation. Int J Cardiol. 2008 Jul 21;127(3):299-306. doi: 10.1016/j.ijcard.2007.11.006. Epub 2008 Jan 8.
- Results publication: PubMed 25129609Frendl G, Sodickson AC, Chung MK, Waldo AL, Gersh BJ, Tisdale JE, Calkins H, Aranki S, Kaneko T, Cassivi S, Smith SC Jr, Darbar D, Wee JO, Waddell TK, Amar D, Adler D; American Association for Thoracic Surgery. 2014 AATS guidelines for the prevention and management of perioperative atrial fibrillation and flutter for thoracic surgical procedures. J Thorac Cardiovasc Surg. 2014 Sep;148(3):e153-93. doi: 10.1016/j.jtcvs.2014.06.036. Epub 2014 Jun 30. No abstract available.
- Results publication: PubMed 26806512Beau J, Kulik A. Topical amiodarone to prevent postoperative atrial fibrillation: Need for further study. J Thorac Cardiovasc Surg. 2016 Feb;151(2):600. doi: 10.1016/j.jtcvs.2015.10.007. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judson B Williams, MD principal investigator
WakeMed Health and Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CardiaMend with the Addition of Amiodarone in people with Post Operative Atrial Fibrillation, run by WakeMed Health and Hospitals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Atrial Fibrillation (time frame: On Average of one Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681182, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.