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Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Atrial Fibrillation, Lung Cancer

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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