RecruitingEarly Phase 1NCT06063538

Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone

A Prospective Study Using Intra-Pericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Cardiac Arterial Bypass Grafting and/or Valve Surgery

Sponsor

University of Chicago

Enrollment

63 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Post-Op Complication

Summary

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.

Eligibility

Min Age: 20 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether placing amiodarone (a heart rhythm-stabilizing drug) directly inside the pericardial sac (the membrane around the heart) during open heart surgery can prevent postoperative atrial fibrillation (POAF), an irregular heartbeat that commonly develops after cardiac surgery. **You may be eligible if...** - You are between 20 and 85 years old - You are scheduled for open-heart surgery through a full sternotomy (breastbone cut), including coronary artery bypass grafting, valve repair or replacement, or ascending aortic repair - You are able to give written informed consent **You may NOT be eligible if...** - You have a known allergy to amiodarone or iodine - You have significant thyroid problems or serious lung disease - You already have atrial fibrillation before surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTCardiaMend in Combination with Amiodarone

The first three patient will receive 600 mg amiodarone into the intact pericardial space. Amiodarone serum levels will be tested at post operative days 2 and 6. The study will only proceed if there is a serum amiodarone level less than 25% of the normal therapeutic level. This should insure lack of systemic toxicity. After the first 3 patients have demonstrated low amiodarone blood levels, a total of up to 60 patients will be enrolled in the study. The CardiaMend patch will saturated per the instructions and be sutured into place. Amiodarone will be dripped directly over the heart.