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

Primary Purpose

Atrial Fibrillation, Post-Op Complication

Status

Not yet recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

CardiaMend in Combination with Amiodarone

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject aged 20-85 years old. Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures. Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes: Coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid) Isolated ascending aortic aneurysm replacement/repair Note: Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own. In sinus rhythm at the time of office visit and prior electrocardiogram (EKG) (note: continuous EKG monitoring for 48 hours is not required). Exclusion Criteria: Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with, testing center or investigator. Any condition which could interfere with the subject's ability to comply with the study. Ongoing participation in an interventional clinical study or during the preceding 30 days. 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. Active skin or deep infection at the site of implantation. History of chronic wounds or wound-healing disorders. Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta). Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion). Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies. Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias. Disease of the left pleura, previous intervention in the left pleural space, or chest deformity. Subjects with end-stage chronic-renal disease / dialysis. STS (Society of Thoracic Surgeons Score) risk score >5.5% for 30 day mortality.

Sites / Locations

The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CardiaMend Pericardial and Epicardial Reconstruction Matrix used in combination with amiodarone

University of Chicago's standard of care in patients undergoing isolated CABG or valve surgery

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Post Operative Atrial Fibrillation

The patients have continuous electrocardiogram (EKG) monitoring until discharge to evaluate for any evidence of atrial fibrillation or atrial flutter which lasts longer than one hour or if less than one hour, requires medical or procedural intervention. Evidence of atrial fibrillation or atrial flutter will be confirmed by 12 lead electrocardiogram by loss or changes to the P wave, as well as irregularities in the QRS wave interval, heart rhythm, or rate. If clinically indicated, patients will receive a monitor for home monitoring per standard of care.

Secondary Outcome Measures

Additional Hospital Time Required Due to Atrial Fibrillation/Flutter

Burden of atrial fibrillation as defined by additional treatment regimen, additional time in intensive care unit (ICU), complications directly associated with atrial fibrillation

Full Information

NCT ID

NCT06063538

First Posted

September 21, 2023

Last Updated

October 3, 2023

Sponsor

University of Chicago

Collaborators

Helios Cardio Inc

1. Study Identification

Unique Protocol Identification Number

NCT06063538

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2023 (Anticipated)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

Collaborators

Helios Cardio Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

This study involves using CardiaMend, an FDA cleared (K210331) pericardial reconstruction matrix with the addition of amiodarone, an FDA approved antiarrhythmic drug, as a prevention of post operative atrial fibrillation. This is a single-center, prospective randomized study enrolling adult subjects undergoing isolated cardiac arterial bypass or valve surgery, via complete median sternotomy. CardiaMend will be used according to the Instructions for Use, and then patted dry to facilitate implantation. 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. A small edge may be left open for drain placement and a small slit for the Left Internal Mammary Artery (LIMA) in case of CABG. The remaining 8 cc of amiodarone will be instilled to the closed pericardial space. Patients will have continuous electrocardiogram (EKG) until discharge. If clinically indicated, patients will receive a monitor for home monitoring per standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Post-Op Complication

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Sequential Assignment

Model Description

To demonstrate that there is no systemic presence of amiodarone, the first three patient will receive 600 mg amiodarone into the intact pericardial space (IPS). 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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CardiaMend Pericardial and Epicardial Reconstruction Matrix used in combination with amiodarone

Arm Type

Experimental

Arm Description

Arm Title

University of Chicago's standard of care in patients undergoing isolated CABG or valve surgery

Arm Type

No Intervention

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

CardiaMend in Combination with Amiodarone

Intervention Description

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.

Primary Outcome Measure Information:

Title

Post Operative Atrial Fibrillation

Description

Time Frame

Through discharge, an average 7 days to 2 weeks

Secondary Outcome Measure Information:

Title

Additional Hospital Time Required Due to Atrial Fibrillation/Flutter

Description

Burden of atrial fibrillation as defined by additional treatment regimen, additional time in intensive care unit (ICU), complications directly associated with atrial fibrillation

Time Frame

Through discharge, an average 7 days to 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kayla Moore, BS

Phone

773-702-8228

kaymoore@bsd.uchicago.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Valluvan Jeevanandam, MD

Phone

773-702-2500

jeevan@bsd.uchicago.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valluvan Jeevanandam, MD

Organizational Affiliation

Director of Heart and Vascular Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aaron Manewith

Phone

773-702-2500

amanewith@bsd.uchicago.edu

First Name & Middle Initial & Last Name & Degree

Arijus Kavaliauskas

Phone

773-702-2500

arijus.kavaliauskas@bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Helios Cardio Inc., who will be the study collaborator will have access to only de-identified form of the data.

Citations:

PubMed Identifier

26833498

Citation

Habbab LM, Chu FV. Intrapericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation. J Card Surg. 2016 Apr;31(4):253-8. doi: 10.1111/jocs.12700. Epub 2016 Feb 2.

Results Reference

background

PubMed Identifier

18191470

Citation

Camm AJ. Safety considerations in the pharmacological management of atrial fibrillation. Int J Cardiol. 2008 Jul 21;127(3):299-306. doi: 10.1016/j.ijcard.2007.11.006. Epub 2008 Jan 8.

Results Reference

background

PubMed Identifier

25129609

Citation

Frendl G, Sodickson AC, Chung MK, Waldo AL, Gersh BJ, Tisdale JE, Calkins H, Aranki S, Kaneko T, Cassivi S, Smith SC Jr, Darbar D, Wee JO, Waddell TK, Amar D, Adler D; American Association for Thoracic Surgery. 2014 AATS guidelines for the prevention and management of perioperative atrial fibrillation and flutter for thoracic surgical procedures. J Thorac Cardiovasc Surg. 2014 Sep;148(3):e153-93. doi: 10.1016/j.jtcvs.2014.06.036. Epub 2014 Jun 30. No abstract available.

Results Reference

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PubMed Identifier

26806512

Citation

Beau J, Kulik A. Topical amiodarone to prevent postoperative atrial fibrillation: Need for further study. J Thorac Cardiovasc Surg. 2016 Feb;151(2):600. doi: 10.1016/j.jtcvs.2015.10.007. No abstract available.

Results Reference

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PubMed Identifier

18294562

Citation

Echahidi N, Pibarot P, O'Hara G, Mathieu P. Mechanisms, prevention, and treatment of atrial fibrillation after cardiac surgery. J Am Coll Cardiol. 2008 Feb 26;51(8):793-801. doi: 10.1016/j.jacc.2007.10.043.

Results Reference

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PubMed Identifier

29161419

Citation

Lowres N, Mulcahy G, Jin K, Gallagher R, Neubeck L, Freedman B. Incidence of postoperative atrial fibrillation recurrence in patients discharged in sinus rhythm after cardiac surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2018 Mar 1;26(3):504-511. doi: 10.1093/icvts/ivx348.

Results Reference

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PubMed Identifier

30876459

Citation

Rego A, Cheung PC, Harris WJ, Brady KM, Newman J, Still R. Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions. J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5.

Results Reference

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PubMed Identifier

25043862

Citation

Feng XD, Wang XN, Yuan XH, Wang W. Effectiveness of biatrial epicardial application of amiodarone-releasing adhesive hydrogel to prevent postoperative atrial fibrillation. J Thorac Cardiovasc Surg. 2014 Sep;148(3):939-43. doi: 10.1016/j.jtcvs.2014.05.049. Epub 2014 May 22.

Results Reference

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PubMed Identifier

8856462

Citation

Ayers GM, Rho TH, Ben-David J, Besch HR Jr, Zipes DP. Amiodarone instilled into the canine pericardial sac migrates transmurally to produce electrophysiologic effects and suppress atrial fibrillation. J Cardiovasc Electrophysiol. 1996 Aug;7(8):713-21. doi: 10.1111/j.1540-8167.1996.tb00579.x.

Results Reference

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PubMed Identifier

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Citation

Darsinos JT, Karli JN, Samouilidou EC, Krumbholz B, Pistevos AC, Levis GM. Distribution of amiodarone in heart tissues following intrapericardial administration. Int J Clin Pharmacol Ther. 1999 Jun;37(6):301-6.

Results Reference

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Citation

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Results Reference

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

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