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

February 20, 2024 updated by: Judson Williams, WakeMed Health and Hospitals

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health and Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
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
Combination product: CardiaMend with the Addition of Amiodarone
The CardiaMend patch will be saturated with Amiodarone prior to being sutured into place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Atrial Fibrillation
Time Frame: Through discharge, an average of 2 weeks
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
Through discharge, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Hospital Time Required Due to Atrial Fibrillation/Flutter
Time Frame: Through discharge, an average of 2 weeks
Burden of atrial fibrillation as defined by additional treatment regimen, additional time in ICU, complications directly associated with atrial fibrillation
Through discharge, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WakeMed Health and Hospitals

Collaborators

Helios Cardio Inc

Investigators

  • Principal Investigator: Judson B Williams, MD, WakeMed Health and Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Actual)

February 6, 2024

Study Completion (Actual)

February 6, 2024

Study Registration Dates

First Submitted

November 25, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1937514

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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