BridgeMD
Prevention study for Atrial Fibrillation, Postoperative
Official title Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
ClinicalTrials.gov ID: NCT06730828
What this study is testing
What is The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)?
The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for atrial fibrillation, postoperative.
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 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.
- Phase 2: a mid-size study of how well it works
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
- people 20-85 years old.
- people able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures.
- people scheduled to undergo open-chest cardiac surgery via complete median sternotomy.
- people in sinus rhythm at the time of office visit and during prior EKG (note: continuous EKG monitoring for 48 hours is not required).
You likely can't join if
- people unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including people institutionalized by court...
- people with a condition that could interfere with their ability to comply with the study.
- people participating in an treatment clinical study or who have participated in such study 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 study.
- people with active skin or deep infection at the site of implantation.
- people with a history of chronic wounds or wound-healing disorders.
See the full eligibility criteria
- people 20-85 years old.
- people able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures.
- people scheduled to undergo open-chest cardiac surgery via complete median sternotomy.
- people in sinus rhythm at the time of office visit and during prior EKG (note: continuous EKG monitoring for 48 hours is not required).
- people unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including people institutionalized by court or official order, or in a dependency relationship with testing center...
- people with a condition that could interfere with their ability to comply with the study.
- people participating in an treatment clinical study or who have participated in such study 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 study.
- people with active skin or deep infection at the site of implantation.
- people with a history of chronic wounds or wound-healing disorders.
- people with known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
- people who are Immune-suppressed or with immune deficiency (properly managed diabetes mellitus is not an exclusion criterion).
- people on concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
- people on the following medications with known interactions with amiodarone: doxorubicin, fosphenytoin, lopinavir-ritonavir, ledipasvir/sofosbuvir, quinidine , procainamide, disopyramide, other Vaughan William class III...
- people with coadministration of any medications which cause QT prolongation
- people 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).
- people with a known history of atrial fibrillation or paroxysmal atrial fibrillation.
- people with a history of ablation for atrial fibrillation.
- people already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
- people with a disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
- people with heart failure (BNP\>1000), low ejection fraction (\<35%), end-stage renal disease (on dialysis or GFR\<20).
- people electing to receive an ablative procedure for atrial fibrillation during the index operation.
- people with prior cardiac surgery via sternotomy.
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, 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 Louisville, Kentucky, 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.