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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through discharge, an average 7 days to 2 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am scheduled for open-chest heart surgery, including procedures like bypass or valve repair.
Select...
I am between 20 and 85 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post Operative Atrial Fibrillation
Secondary outcome measures
Additional Hospital Time Required Due to Atrial Fibrillation/Flutter

Side effects data

From 2008 Phase 4 trial • 130 Patients • NCT00127712
34%
Hypotension
2%
death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Amiodarone

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).

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,714 Total Patients Enrolled
2 Trials studying Postoperative Complications
228 Patients Enrolled for Postoperative Complications
Helios Cardio IncUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Valluvan Jeevanandam, MDPrincipal InvestigatorDirector of Heart and Vascular Center
3 Previous Clinical Trials
69 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there remaining vacancies for participants in this trial?

"The study, which initially opened on November 1st 2023 and is no longer accepting applicants, has been documented at clinicaltrials.gov as inactive. Despite this inactivity, 613 other experiments are still actively recruiting participants."

Answered by AI

To which patient demographics is this research open?

"To be eligible for this medical study, an individual must have a diagnosis of atrial fibrillation and reside between the ages of 20 to 85. A total of 63 participants are slated to join in on the trial."

Answered by AI

Does this research encompass individuals aged 40 and older?

"As per the stipulated enrollment conditions, patients must be between 20 and 85 years of age to qualify for this clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone
2024. "Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06063538.
~42 spots leftby Nov 2024
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