Viewing Study NCT00300495


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Study NCT ID: NCT00300495
Status: TERMINATED
Last Update Posted: 2017-04-28
First Post: 2006-03-08
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection
Sponsor: Beth Israel Deaconess Medical Center
Organization:

Study Overview

Official Title: Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection
Status: TERMINATED
Status Verified Date: 2017-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Unable to accrual total number of participants during study period.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.
Detailed Description: Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.

We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: