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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06063538
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • CardiaMend in Combination with Amiodarone — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Feb 15, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CardiaMend Pericardial and Epicardial Reconstruction Matrix used in combination with amiodarone
    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.
  • No Intervention: University of Chicago's standard of care in patients undergoing isolated CABG or valve surgery
    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).

Primary Outcome Measure

Post Operative Atrial Fibrillation [ Time Frame: Through discharge, an average 7 days to 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637
Aaron Manewith
[email protected]
773-702-2500
Arijus Kavaliauskas
[email protected]
773-702-2500

Find similar trials in Chicago, IL

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
The University of Chicago· Chicago, IL

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