Atrial Fibrillation, PostoperativePhase 1/2AMIOMENDNCT06730828
Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
A Phase 1/2 study testing The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) in people with Atrial Fibrillation, Postoperative, run by Helios Cardio Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein). Participating subjects must be 20-85 year old males or females. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Postoperative
- What is being tested?
- The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to May 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Subjects 20-85 years old.
- Subjects able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures.
- Subjects scheduled to undergo open-chest cardiac surgery via complete median sternotomy.
- Subjects in sinus rhythm at the time of office visit and during prior EKG (note: continuous EKG monitoring for 48 hours is not required).
Who cannot join
- Subjects unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including subjects institutionalized by court or official order, or in a dependency relationship with testing center or investigator.
- Subjects with a condition that could interfere with their ability to comply with the study.
- Subjects participating in an interventional clinical study or who have participated in such study 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 study.
- Subjects with active skin or deep infection at the site of implantation.
- Subjects with a history of chronic wounds or wound-healing disorders.
Show all 19Show fewer
- Subjects with known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
- Subjects who are Immune-suppressed or with immune deficiency (properly managed diabetes mellitus is not an exclusion criterion).
- Subjects on concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
- Subjects on the following medications with known interactions with amiodarone: doxorubicin, fosphenytoin, lopinavir-ritonavir, ledipasvir/sofosbuvir, quinidine , procainamide, disopyramide, other Vaughan William class III agents including dofetilide, dronedarone, ibutilide and vernakalant.
- Subjects with coadministration of any medications which cause QT prolongation
- Subjects with implantable cardiac devices (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD), and pacemakers).
- Subjects with a known history of atrial fibrillation or paroxysmal atrial fibrillation.
- Subjects with a history of ablation for atrial fibrillation.
- Subjects already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
- Subjects with a disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
- Subjects with heart failure (BNP>1000), low ejection fraction (<35%), end-stage renal disease (on dialysis or GFR<20).
- Subjects electing to receive an ablative procedure for atrial fibrillation during the index operation.
- Subjects with prior cardiac surgery via sternotomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Jaimin Trivedi, MD FACC, 708-606-3115, jaimin.trivedi@louisville.edu
Terry Blanton, BSN RN, 502-587-4381, mary.blanton@louisville.edu
About this study
Official title: Use of Amiodarone-Infused CardiaMend (CardiaMend-Amiodarone) Patches for the Prevention of New-Onset Postoperative Atrial Fibrillation (POAF) in Subjects Undergoing Cardiac Surgery
The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein). Participating subjects must be 20-85 year old males or females. Up to 80 participants having cardiac surgery at the University of Louisville will be involved in this study.
The main questions this study aims to answer are:
Read more
- Is the patch safe?
- Does the patch lower the rate of atrial fibrillation (irregular heart rhythm) after cardiac surgery?
Researchers will compare up to 3 different doses of the amiodarone patches (low, medium and high) to the usual treatment (Standard of Care) to see if there are differences (increases or decreases) in heart rhythms after cardiac surgery across study groups.
Participants will be placed in one of 4 study groups:
- Standard of Care (20 participants)
- Low dose patch (20 participants)
- Medium dose patch (20 participants)
- High dose patch (20 participants)
Participants will be monitored closely by their doctor(s) during the study and would:
- Agree to participate after having their doctor, or a member of the team, explain the study in detail and allowing them to ask any questions they would like.
- Sign an Informed Consent Form which will describe the study and tests in full.
- Agree to have their doctor and his/her research team record your medical information, draw blood, and perform electrocardiograms, or EKGs (quick, painless test that measures the electrical activity of the heart) and echocardiograms (image of heart) to monitor their heart.
- Agree to receive training on the portable EKG recorder and to use it at home approximately 30 days and 6 months after their surgery to monitor their heart.
- Agree to return to the hospital approximately 30 days and 6 months after their surgery for a study visit.
Participant involvement will be approximately 7 months total.
Read the detailed description
The purpose of this study is to determine the safety of a drug-device treatment for the prevention of postoperative atrial fibrillation following open heart surgery. Approximately a quarter of patients will develop atrial fibrillation after open heart surgery. Atrial fibrillation is a type of irregular heart rhythm or arrhythmia, in which the heart does not pump effectively. This can lead to problems such as stroke, palpitations (an abnormal heart rhythm that can feel like your heart is racing or pounding) and prolonged hospital stays. The goal of this study is to determine if the application of a medication (amiodarone) containing patch on the surface of the heart at the time of surgery is safe, which may lead to a treatment to lower the rate of atrial fibrillation in patients undergoing open heart surgery. The study drug-device is not yet FDA approved.
- Conditions
- Atrial Fibrillation, Postoperative
- Being tested
- The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)
- Keywords
- post Operative Atrial Fibrillation, Arrhythmias, Cardiac Heart Diseases, Cardiovascular Diseases, Atrial Fibrillation, Anti-Arrhythmia Agents
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)Combination product
Intervention includes a topical, atrial-specific, amiodarone infused CardiaMend patch in the operating room and applied onto the epicardial surface biatrially
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 20 subjects in the control group, which is the standard of care (i.e., no CardiaMend-Amioda | No intervention | Subjects in treatment Group 1 (control) will receive no CardiaMend-Amiodarone patches. |
| Group 2: 20 subjects receiving CardiaMend-Amiodarone infused with 70 mg of amiodarone | Experimental | Subjects in Group 2 (70 mg) will receive three patches each as follows:
* One patch (5x6 cm) will be placed on top of the right atrium;
* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and
* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium Receives: Combination Product: The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) |
| Group 3: 20 subjects receiving CardiaMend-Amiodarone infused with 150 mg of amiodarone. | Experimental | Subjects in Group 3 (150 mg) will receive three patches each as follows:
* One patch (5x6 cm) will be placed on top of the right atrium;
* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and
* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium Receives: Combination Product: The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) |
| Group 4: 20 subjects receiving CardiaMend-Amiodarone infused with 300 mg of amiodarone. | Experimental | Subjects in Group 4 (300 mg) will receive three patches each as follows:
* One patch (5x6 cm) will be placed on top of the right atrium;
* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and
* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium Receives: Combination Product: The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, defined as major adverse cardiac and cerebrovascular events (MACCE), up to subject discharge.
MACCE is defined as in-hospital all-cause death, acute myocardial infarction (AMI), or ischemic stroke.
Measured: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner
Secondary outcomes (7)
Incidence of postoperative atrial fibrillation (POAF)
Incidence of POAF up to patient discharge; defined as subject experiencing 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: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner
Migration of cardiamend-amiodarone patches.
Confirm placement of patches with non-contrast thoracic CT scan on first 3 subjects from Group 2 (70 mg) prior to discharge.
Measured: One day before the date of hospital discharge up to two months
Length of Stay.
Length of initial hospital stay.
Measured: From the day of the index procedure to hospital discharge up to 2 months
Hospital readmission.
30 day readmission from discharge due to all cause complications based upon STS data
Measured: Up to 30 days post-subject hospital discharge.
POAF duration
Duration of POAF, if observed.
Measured: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner
Discharge on antiarrhythmic drug.
Discharge on antiarrhythmic drug, if POAF observed.
Measured: At subject hospital discharge to a maximum of 2 months post-index procedure date.
Discharge on oral anticoagulation.
Discharge on oral anticoagulation, if POAF observed.
Measured: At subject hospital discharge to a maximum of 2 months post-index procedure date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PostoperativeStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects undergoing cardiac surgery via complete median sternotomy
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Cardio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark S. Slaughter, MD, Principal investigator, University of Louisville Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730828
- Sponsor's protocol ID
- CP001
- Acronym
- AMIOMEND
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Amiodarone-Infused CardiaMend (CardiaMend-Amiodarone) Patches for the Prevention of New-Onset Postoperative Atrial Fibrillation (POAF) in Subjects Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06730828
- Acronym / sponsor ID
- AMIOMEND / CP001
- Conditions
- Atrial Fibrillation, Postoperative
- Keywords
- post Operative Atrial Fibrillation, Arrhythmias, Cardiac Heart Diseases, Cardiovascular Diseases, Atrial Fibrillation, Anti-Arrhythmia Agents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Helios Cardio Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Dec 2024 (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 goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein). Participating subjects must be 20-85 year old males or females. Up to 80 participants having cardiac surgery at the University of Louisville will be involved in this study.
The main questions this study aims to answer are:
- Is the patch safe?
- Does the patch lower the rate of atrial fibrillation (irregular heart rhythm) after cardiac surgery?
Researchers will compare up to 3 different doses of the amiodarone patches (low, medium and high) to the usual treatment (Standard of Care) to see if there are differences (increases or decreases) in heart rhythms after cardiac surgery across study groups.
Participants will be placed in one of 4 study groups:
- Standard of Care (20 participants)
- Low dose patch (20 participants)
- Medium dose patch (20 participants)
- High dose patch (20 participants)
Participants will be monitored closely by their doctor(s) during the study and would:
- Agree to participate after having their doctor, or a member of the team, explain the study in detail and allowing them to ask any questions they would like.
- Sign an Informed Consent Form which will describe the study and tests in full.
- Agree to have their doctor and his/her research team record your medical information, draw blood, and perform electrocardiograms, or EKGs (quick, painless test that measures the electrical activity of the heart) and echocardiograms (image of heart) to monitor their heart.
- Agree to receive training on the portable EKG recorder and to use it at home approximately 30 days and 6 months after their surgery to monitor their heart.
- Agree to return to the hospital approximately 30 days and 6 months after their surgery for a study visit.
Participant involvement will be approximately 7 months total.
Detailed description
The purpose of this study is to determine the safety of a drug-device treatment for the prevention of postoperative atrial fibrillation following open heart surgery. Approximately a quarter of patients will develop atrial fibrillation after open heart surgery. Atrial fibrillation is a type of irregular heart rhythm or arrhythmia, in which the heart does not pump effectively. This can lead to problems such as stroke, palpitations (an abnormal heart rhythm that can feel like your heart is racing or pounding) and prolonged hospital stays. The goal of this study is to determine if the application of a medication (amiodarone) containing patch on the surface of the heart at the time of surgery is safe, which may lead to a treatment to lower the rate of atrial fibrillation in patients undergoing open heart surgery. The study drug-device is not yet FDA approved.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Subjects undergoing cardiac surgery via complete median sternotomy
| Arm | Type | Receives |
|---|---|---|
| Group 1: 20 subjects in the control group, which is the standard of care (i.e., no CardiaMend-Amioda | No intervention | –Subjects in treatment Group 1 (control) will receive no CardiaMend-Amiodarone patches. |
| Group 2: 20 subjects receiving CardiaMend-Amiodarone infused with 70 mg of amiodarone | Experimental | Combination Product: The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)Subjects in Group 2 (70 mg) will receive three patches each as follows: * One patch (5x6 cm) will be placed on top of the right atrium; * One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and * One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium |
| Group 3: 20 subjects receiving CardiaMend-Amiodarone infused with 150 mg of amiodarone. | Experimental | Combination Product: The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)Subjects in Group 3 (150 mg) will receive three patches each as follows: * One patch (5x6 cm) will be placed on top of the right atrium; * One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and * One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium |
| Group 4: 20 subjects receiving CardiaMend-Amiodarone infused with 300 mg of amiodarone. | Experimental | Combination Product: The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)Subjects in Group 4 (300 mg) will receive three patches each as follows: * One patch (5x6 cm) will be placed on top of the right atrium; * One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and * One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects 20-85 years old.
- Subjects able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures.
- Subjects scheduled to undergo open-chest cardiac surgery via complete median sternotomy.
- Subjects in sinus rhythm at the time of office visit and during prior EKG (note: continuous EKG monitoring for 48 hours is not required).
Key exclusion criteria (19 listed)
- Subjects unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including subjects institutionalized by court or official order, or in a dependency relationship with testing center or investigator.
- Subjects with a condition that could interfere with their ability to comply with the study.
- Subjects participating in an interventional clinical study or who have participated in such study 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 study.
- Subjects with 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 |
|---|---|---|
| The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)Intervention includes a topical, atrial-specific, amiodarone infused CardiaMend patch in the operating room and applied onto the epicardial surface biatrially | Combination product | Group 2: 20 subjects receiving CardiaMend-Amiodarone infused with 70 mg of amiodarone, Group 3: 20 subjects receiving CardiaMend-Amiodarone infused with 150 mg of amiodarone., Group 4: 20 subjects receiving CardiaMend-Amiodarone infused with 300 mg of amiodarone. |
Primary outcome
Safety, defined as major adverse cardiac and cerebrovascular events (MACCE), up to subject discharge.
Time frame: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner
MACCE is defined as in-hospital all-cause death, acute myocardial infarction (AMI), or ischemic stroke.
7 secondary outcomes
Incidence of postoperative atrial fibrillation (POAF)
Time frame: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner
Migration of cardiamend-amiodarone patches.
Time frame: One day before the date of hospital discharge up to two months
Length of Stay.
Time frame: From the day of the index procedure to hospital discharge up to 2 months
Hospital readmission.
Time frame: Up to 30 days post-subject hospital discharge.
POAF duration
Time frame: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner
Discharge on antiarrhythmic drug.
Time frame: At subject hospital discharge to a maximum of 2 months post-index procedure date.
Discharge on oral anticoagulation.
Time frame: At subject hospital discharge to a maximum of 2 months post-index procedure date.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Mark S. Slaughter, MD principal investigator
University of Louisville Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) in people with Atrial Fibrillation, Postoperative, run by Helios Cardio Inc. 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 4 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaimin Trivedi, MBBS FACC (502-588-7638, jaimin.trivedi@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, defined as major adverse cardiac and cerebrovascular events (MACCE), up to subject discharge. (time frame: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner). 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 12 Dec 2024.