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Prevention of Post-OP AFib Using Combination of CardiaMend and Amiodarone (CAMP POAF)

Primary Purpose

Post Operative Atrial Fibrillation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CardiaMend with the Addition of Amiodarone
Sponsored by
WakeMed Health and Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative 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) or valve repair/replacement, or Inclusionary valve repair/replacement procedures for the primary reason for surgery include: aortic valve repair/replacement, mitral valve repair/replacement. 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 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. The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers). Known history of atrial fibrillation or paroxysmal atrial fibrillation. History of ablation for atrial fibrillation. 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. Subjects with heart failure (BNP>1000), low ejection fraction (<35%), end stage renal disease (on dialysis or creatinine >1.8). STS risk >5.5% for 30 day mortality. Patients electing to receive an ablative procedure for atrial fibrillation during the index operation.

Sites / Locations

  • WakeMed Health and HospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

All patients who are enrolled into the study will receive the treatment. This includes the CardiaMend which should be used according to the Instructions for Use with the exception that device hydration is performed with 3 ampules of amiodarone (150mg/3ml) instead of room temperature saline. For best results, the device should be fixed in place using a continuous or interrupted stitch (approximately 1 stitch per cm) to approximate the edge of the pericardial defect. The closed defect should not put pressure on the underlying structures. A non-absorbable monofilament suture is preferred such as 5-0 or 4-0 prolene. A small edge may be left open for drain placement and a small slit for LIMA in case of CABG

Outcomes

Primary Outcome Measures

Post Operative Atrial Fibrillation
The patient have continuous ECG 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

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 ICU, complications directly associated with atrial fibrillation

Full Information

First Posted
November 25, 2022
Last Updated
January 20, 2023
Sponsor
WakeMed Health and Hospitals
Collaborators
Helios Cardio Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05681182
Brief Title
Prevention of Post-OP AFib Using Combination of CardiaMend and Amiodarone
Acronym
CAMP POAF
Official Title
A Prospective Pilot Study of the Combination of CardiaMend and Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Isolated Cardiac Arterial Bypass Grafting or Isolated Valve Surgery (CAMP POAF)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
WakeMed Health and Hospitals
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
No

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 isolated cardiac arterial bypass grafting (CABG) or valve surgery.
Detailed Description
This study will investigate CardiaMend, an FDA cleared (K210331) pericardial reconstruction matrix used in combination with amiodarone, an FDA approved antiarrhythmic drug, as a prevention of POAF. This is a single-center, prospective, pilot study, enrolling adult subjects undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy. CardiaMend should be used according to the Instructions for Use with the exception that device hydration is performed with 3 ampules of amiodarone (150mg/3ml) instead of room temperature saline. For best results, the device should be fixed in place using a continuous or interrupted stitch (approximately 1 stitch per cm) to approximate the edge of the pericardial defect. The closed defect should not put pressure on the underlying structures. A non-absorbable monofilament suture is preferred such as 5-0 or 4-0 prolene. A small edge may be left open for drain placement and a small slit for LIMA in case of CABG. Patients will have continuous 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
Post Operative Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Patients undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
All patients who are enrolled into the study will receive the treatment. This includes the CardiaMend which should be used according to the Instructions for Use with the exception that device hydration is performed with 3 ampules of amiodarone (150mg/3ml) instead of room temperature saline. For best results, the device should be fixed in place using a continuous or interrupted stitch (approximately 1 stitch per cm) to approximate the edge of the pericardial defect. The closed defect should not put pressure on the underlying structures. A non-absorbable monofilament suture is preferred such as 5-0 or 4-0 prolene. A small edge may be left open for drain placement and a small slit for LIMA in case of CABG
Intervention Type
Combination Product
Intervention Name(s)
CardiaMend with the Addition of Amiodarone
Intervention Description
The CardiaMend patch will be saturated with Amiodarone prior to being sutured into place.
Primary Outcome Measure Information:
Title
Post Operative Atrial Fibrillation
Description
The patient have continuous ECG 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
Time Frame
Through discharge, an average of 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 ICU, complications directly associated with atrial fibrillation
Time Frame
Through discharge, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) or valve repair/replacement, or Inclusionary valve repair/replacement procedures for the primary reason for surgery include: aortic valve repair/replacement, mitral valve repair/replacement. 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 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. The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers). Known history of atrial fibrillation or paroxysmal atrial fibrillation. History of ablation for atrial fibrillation. 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. Subjects with heart failure (BNP>1000), low ejection fraction (<35%), end stage renal disease (on dialysis or creatinine >1.8). STS risk >5.5% for 30 day mortality. Patients electing to receive an ablative procedure for atrial fibrillation during the index operation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rhonda D Norton, CCRC
Phone
919-350-5252
Email
rnorton@wakemed.org
First Name & Middle Initial & Last Name or Official Title & Degree
LaMonica Daniel, CCRP
Phone
919-350-7438
Email
ladaniel@wakemed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judson B Williams, MD
Organizational Affiliation
WakeMed Health and Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
WakeMed Health and Hospitals
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaMonica Daniel
Phone
919-350-7438
Email
ladaniel@wakemed.org
First Name & Middle Initial & Last Name & Degree
Rhonda D Norton
Phone
919-350-5252
Email
rnorton@wakemed.org
First Name & Middle Initial & Last Name & Degree
Judson B Williams, MD

12. IPD Sharing Statement

Citations:
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
result
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
result
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
result
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
result
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
result
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
result
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
result

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Prevention of Post-OP AFib Using Combination of CardiaMend and Amiodarone

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