Prevention trial 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?
This is an investigational combination of a heart patch and a liquid medicine being studied to help prevent atrial fibrillation after heart surgery. The amiodarone is designed to help control heart rhythm, while the CardiaMend patch is designed to support the healing of the heart's outer layer.
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
- This study checks if adding a heart medicine to a new device helps stop irregular heartbeats after surgery.
- Who it's for
- People scheduled for heart bypass or valve surgery.
- What's involved
- Participants will receive a specific heart medicine and a device during their surgery.
- Time commitment
- The study follows participants through their surgery and recovery period.
- 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.
- 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...
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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.