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Prevention study for Atrial Fibrillation
Official title Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone
ClinicalTrials.gov ID: NCT06063538
What this study is testing
What is CardiaMend in Combination with Amiodarone?
CardiaMend in Combination with Amiodarone is an investigational medicine, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 cardiac arterial bypass grafting (CABG) or valve surgery.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 85
You may be able to join if
- 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) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid)
- Isolated ascending aortic aneurysm replacement/repair
You likely can't join if
- Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including people who are...
- Any condition which could interfere with the subject's ability to comply with the study.
- Ongoing participation in an treatment clinical study or during the preceding 30 days.
- Female people who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the course of...
- Active skin or deep infection at the site of implantation.
- History of chronic wounds or wound-healing disorders.
See the full eligibility criteria
- 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) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid)
- Isolated ascending aortic aneurysm replacement/repair
- 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 electrocardiogram (EKG) (note: continuous EKG monitoring for 48 hours is not required).
- Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including people who are institutionalized by court or official order, or in a dependency relationship with...
- Any condition which could interfere with the subject's ability to comply with the study.
- Ongoing participation in an treatment clinical study or during the preceding 30 days.
- Female people 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.
- Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
- Immune-suppressed people, immune-deficiency people (properly managed diabetes mellitus is not an exclusion criterion).
- Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
- 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.
- people with end-stage chronic-renal disease / dialysis.
- STS (Society of Thoracic Surgeons Score) risk score \>5.5% for 30 day mortality.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.