This trial looks at how CardiaMend and amiodarone can help prevent atrial fibrillation after heart surgery.
- Post-operative Atrial Fibrillation
This is further along than 93% of similar trials
1 Primary · 1 Secondary · Reporting Duration: Through discharge, an average of 2 weeks
Additional Hospital Time Required Due to Atrial Fibrillation/Flutter
Post Operative Atrial Fibrillation
This is further along than 85% of similar trials
0 Treatment Group
30 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 4
Screening: ~3 weeks
Reporting: through discharge, an average of 2 weeks
Who is running the clinical trial?
WakeMed Health and HospitalsLead Sponsor
5 Previous Clinical Trials
3,623 Total Patients Enrolled
Helios Cardio IncUNKNOWN
Judson B Williams, MDPrincipal InvestigatorWakeMed Health and Hospitals
Age 20 - 85 · All Participants · 4 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Judson Williams 2023. "Prevention of Post-OP AFib Using Combination of CardiaMend and Amiodarone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05681182.