Phase 2 Atrial Fibrillation Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People between 20 and 85 years old.
• People who are able to give written consent on their own free will and are willing to follow the study procedures.
• People who are already scheduled to have open-chest heart surgery through a full cut down the centre of the chest (called a median sternotomy).
• People whose heart is in a normal, regular rhythm (called sinus rhythm) at their clinic visit and on a recent heart tracing (ECG/EKG).

Who may not be able to join:

• People who are unable to give informed written consent, are unlikely to cooperate, or are not legally able to consent — including people placed in an institution by a court order or who are in a dependent relationship with the study centre or researcher.
• People who have a health condition that may make it difficult to follow the study requirements.
• People who are currently taking part in another interventional clinical trial, or who have done so in the past 30 days.
• Women who are pregnant, breastfeeding, were pregnant in the last three months, or plan to become pregnant during the study.
• People who have an active skin or deep infection at the area of the body where the device would be placed.
• People with a history of wounds that do not heal normally or chronic wound problems.
• People with known connective tissue disorders, such as Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, or Osteogenesis imperfecta.
• People whose immune system is suppressed or who have an immune deficiency (note: well-managed diabetes on its own is not a reason for exclusion — confirm with trial site).
• People currently taking oral or intravenous corticosteroids (such as prednisone) or other ongoing anti-inflammatory medications.
• People taking certain medications known to interact with amiodarone, including doxorubicin, fosphenytoin, lopinavir-ritonavir, ledipasvir/sofosbuvir, quinidine, procainamide, disopyramide, dofetilide, dronedarone, ibutilide, or vernakalant.
• People taking any medications known to prolong the QT interval (a specific measurement on a heart tracing — confirm with trial site).
• People who already have an implanted heart device, such as a pacemaker, defibrillator (ICD), or cardiac resynchronisation therapy device (CRT or CRT-D).
• People with a known history of atrial fibrillation (an irregular heart rhythm) or episodes of paroxysmal atrial fibrillation (intermittent irregular heart rhythm).
• People who have previously had an ablation procedure to treat atrial fibrillation.
• People already being treated with amiodarone for atrial fibrillation or abnormal heart rhythms.
• People with disease affecting the left pleura (lining around the lung), a previous procedure in the left chest cavity, or a significant chest deformity.
• People with severe heart failure (based on a blood marker called BNP being above 1000), a very low heart pumping function (ejection fraction below 35%), or end-stage kidney disease (on dialysis or with a kidney filtration rate below 20).
• People who plan to have an ablation procedure for atrial fibrillation performed at the same time as their heart surgery.
• People who have previously had heart surgery through a sternotomy (a cut down the centre of the chest).

Important: Always verify eligibility with the trial site directly before applying.