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

NCT05681182 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: 1937514
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

  Through discharge, an average of 2 weeks

Secondary Outcomes (1)

• Additional Hospital Time Required Due to Atrial Fibrillation/Flutter

  Through discharge, an average of 2 weeks

Study Arms (1)

Single Arm

OTHER

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

Interventions

CardiaMend with the Addition of Amiodarone COMBINATION_PRODUCT

The CardiaMend patch will be saturated with Amiodarone prior to being sutured into place.

Single Arm

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• WakeMed Health and Hospitals: lead
• Helios Cardio Inc.: collaborator

Study Sites (1)

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610, United States

Location

Related Publications (7)

• 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.

  PMID: 30876459 RESULT

• 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.

  PMID: 18294562 RESULT

• 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.

  PMID: 29161419 RESULT

• 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.

  PMID: 26833498 RESULT

• 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.

  PMID: 18191470 RESULT

• 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.

  PMID: 25129609 RESULT

• 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.

  PMID: 26806512 RESULT

Study Officials

• Judson B Williams, MD

  WakeMed Health and Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: January 12, 2023
• Study Start: January 20, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

US (1)