Trial Information
Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection
Inclusion Criteria:
- Resectable lung nodule or mass
Exclusion Criteria:
- Allergy to amiodarone
- Currently taking amiodarone
- Documented atrial fibrillation within past 12 months
- Known pulmonary fibrosis
- Known hepatic dysfunction
- Thyroid disease
- 2nd or 3rd degree heart block
- Severe SA node disease
- Bradycardia-induced syncope
- Pregnancy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Incidence of post-operative atrial fibrillation
Outcome Time Frame:
30 days
Safety Issue:
No
Principal Investigator
Malcolm M DeCamp, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Institutional Review Board
Study ID:
2005P000376
NCT ID:
NCT00300495
Start Date:
February 2006
Completion Date:
March 2011
Related Keywords:
- Atrial Fibrillation
- Lung Cancer
- Atrial fibrillation
- Lung cancer
- Pulmonary resection
- Post-operative complications
- Atrial Fibrillation
- Lung Neoplasms
Name | Location |
Beth Israel Deaconess Medical Center |
Boston, Massachusetts 02215 |