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Intra-Pericardial Amiodarone for Postoperative Atrial Fibrillation

Phase < 1

Recruiting

Led By Valluvan Jeevanandam, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy including coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid), isolated ascending aortic aneurysm replacement/repair, and left atrial appendage (LAA) procedures if CABG and/or valve repair or replacement is the qualifying surgical procedure

Subject aged 20-85 years old

Must not have

Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias

Female subjects who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the course of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through discharge, an average 7 days to 2 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new combo of drugs to help prevent an irregular heartbeat after heart surgery.

Who is the study for?

This trial is for adults aged 20-85 undergoing open-chest heart surgery, such as bypass or valve repair, who can consent and follow study procedures. Excluded are those with certain conditions that affect compliance, ongoing clinical study participation, pregnancy/breastfeeding recently or during the study, infections at implant sites, connective tissue diseases, immune deficiencies (except well-managed diabetes), high surgical risk scores (>5.5%), chronic wounds or on amiodarone already.

What is being tested?

The trial tests a combination of CardiaMend with Amiodarone to prevent postoperative atrial fibrillation in patients after cardiac surgery like artery bypass grafting or valve surgery. It aims to see if this combo is more effective than current methods used.

What are the potential side effects?

Amiodarone may cause side effects including lung inflammation (pneumonitis), liver enzyme changes indicating potential liver damage, thyroid disorders either overactive (hyperthyroidism) or underactive (hypothyroidism), skin reactions when exposed to sunlight and nerve damage leading to tremors or poor coordination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for open-chest heart surgery, including procedures like bypass or valve repair.

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I am between 20 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking amiodarone for heart rhythm problems.

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I am not pregnant, breastfeeding, have been pregnant in the last 3 months, nor plan to become pregnant during the study.

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I have an infection where my implant will be placed.

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I have a history of chronic wounds or problems with wound healing.

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I have a condition affecting the left side of my chest, including previous surgeries or deformities.

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I am on dialysis for end-stage kidney disease.

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My heart surgery risk score is above 5.5% for dying within 30 days.

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I am able to understand and willing to sign the consent form for the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through discharge, an average 7 days to 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through discharge, an average 7 days to 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through discharge, an average 7 days to 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post Operative Atrial Fibrillation

Secondary study objectives

Additional Hospital Time Required Due to Atrial Fibrillation/Flutter

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CardiaMend Pericardial and Epicardial Reconstruction Matrix used in combination with amiodaroneExperimental Treatment1 Intervention

Patients randomized to this study arm includes the CardiaMend which will be used according to the instructions for use. It will be patted dry to facilitate implantation. Pieces will be cut to cover the right and left atria. The remaining piece will be contoured to close the anterior pericardial space. Four ampules of amiodarone (150mg/3ml; 12cc total volume) will be drawn into a syringe. 2cc will be dripped over the right atrium and a small CardiaMend patch placed to cover this area. Another 2cc will be used over the left atrium and covered with the CardiaMend. The anterior pericardial space will be closed without putting pressure on the underlying structures using the CardiaMend attached to the native pericardium utilizing running 4-0 monofilament suture.

Group II: University of Chicago's standard of care in patients undergoing isolated CABG or valve surgeryActive Control1 Intervention

The standard of care for this study at The University of Chicago is to ligate the left atrial appendage (LAA) during the proposed cardiac surgery (intra-operative) to reduce the occurrence of post operative atrial fibrillation (A-FIB) in combination with amiodarone injections (if applicable).

0 / 10Eligibility criteria met