POAFNCT05641883
CardiaMend and Amiodarone for the Prevention of POAF
A study testing CardiaMend with antiarrhythmic in people with POAF and Atrial Fibrillation, run by Saint Alphonsus Regional Medical Center.
Trial summary
The principal purpose of this investigator-initiated trial is to study the use of the CardiaMend device soaked in the anti-arrhythmic drug amiodarone, and how it may decrease the development of atrial fibrillation in patients that have undergone a coronary artery bypass surgery, or isolated valve surgery. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- POAF, Atrial Fibrillation
- What is being tested?
- CardiaMend with antiarrhythmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21-85 years
- Able to provide written informed consent, understand and be willing to comply with study-related procedures.
- Scheduled to undergo open-chest cardiac surgery via complete median sternotomy for coronary artery bypass graft (CABG), or isolated valve repair/replacement.
- Inclusionary valve repair/replacement procedures with the primary reason for surgery inclusive of aortic valve repair/replacement or mitral valve repair/replacement.
- 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 consultation and on a previous EKG, or no history of atrial fibrillation (note: continuous ECG monitoring for 48 hours is not required)
Who cannot join
- 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 a pregnancy 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).
- 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 (in any form including paroxysmal atrial fibrillation).
- History of ablation for atrial fibrillation.
- Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias during the procedure.
- 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.
Trial locations and contacts
No sites are listed yet.
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 Coronary Artery Bypass Grafting or Isolated Valve Surgery
The principal purpose of this investigator-initiated trial is to study the use of the CardiaMend device soaked in the anti-arrhythmic drug amiodarone, and how it may decrease the development of atrial fibrillation in patients that have undergone a coronary artery bypass surgery, or isolated valve surgery.
- Conditions
- POAF, Atrial Fibrillation
- Being tested
- CardiaMend with antiarrhythmic
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiaMend with antiarrhythmicCombination product
Pericardial patch with antiarrhythmic drug (amiodarone) topically applied
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All eligible patients that are enrolled with receive the CardiaMend patch soaked in amiodarone Receives: Combination Product: CardiaMend with antiarrhythmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POAF
Incidence of POAF up to patient discharge as defined as atrial fibrillation/flutter (AF) after OR exit that lasted longer than one hour, or lasted less than one hour but required medical or procedural intervention.
Measured: 5 days
Secondary outcomes (1)
Time until discharge
Burden of atrial fibrillation as defined by additional treatment regimen, additional time in ICU, and/or complications directly associated with atrial fibrillation.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POAFStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open label, single arm study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Alphonsus Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Saeid Farivar, MD, Saint Alphonsus Regional Medical Center
- Investigators
- Robert Saeid Farivar, MD, PhD, Principal investigator, Saint Alphonsus Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641883
- Sponsor's protocol ID
- Pro00066172
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. 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 Coronary Artery Bypass Grafting or Isolated Valve Surgery
- ClinicalTrials.gov ID
- NCT05641883
- Acronym / sponsor ID
- Pro00066172
- Conditions
- POAF, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Saint Alphonsus Regional Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal purpose of this investigator-initiated trial is to study the use of the CardiaMend device soaked in the anti-arrhythmic drug amiodarone, and how it may decrease the development of atrial fibrillation in patients that have undergone a coronary artery bypass surgery, or isolated valve surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open label, single arm study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Combination Product: CardiaMend with antiarrhythmicAll eligible patients that are enrolled with receive the CardiaMend patch soaked in amiodarone |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 21-85 years
- Able to provide written informed consent, understand and be willing to comply with study-related procedures.
- Scheduled to undergo open-chest cardiac surgery via complete median sternotomy for coronary artery bypass graft (CABG), or isolated valve repair/replacement.
- Inclusionary valve repair/replacement procedures with the primary reason for surgery inclusive of aortic valve repair/replacement or mitral valve repair/replacement.
- 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.
Key exclusion criteria (17 listed)
- 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 a pregnancy 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 antiarrhythmicPericardial patch with antiarrhythmic drug (amiodarone) topically applied | Combination product | Experimental |
Primary outcome
Incidence of POAF
Time frame: 5 days
Incidence of POAF up to patient discharge as defined as atrial fibrillation/flutter (AF) after OR exit that lasted longer than one hour, or lasted less than one hour but required medical or procedural intervention.
1 secondary outcome
Time until discharge
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for POAF
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The DefiPace Study
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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.
Robert Saeid Farivar, MD, PhD principal investigator
Saint Alphonsus Regional Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing CardiaMend with antiarrhythmic in people with POAF and Atrial Fibrillation, run by Saint Alphonsus Regional Medical Center.
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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paige Nesbitt (208-367-8386, paige.nesbitt@saintalphonsus.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POAF (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2022.