Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients

Completed · Phase 2

Conditions studied: Atrial Fibrillation, Lung Transplant; Complications

In brief

This study will prospectively evaluate the use of an amiodarone releasing hydrogel applied to the pulmonary veins and atria at the time of lung transplantation. This study will include patients undergoing lung transplantation at Jewish Hospital, Louisville KY. The prospective group will be compared to historical controls from the same institution. Investigators will access medical records and database entries for those patients undergoing lung transplantation after January 1st 2005 in order to obtain matched controls for analysis. Informed consent will be obtained from the prospective cohort prior to patient enrollment. This pilot study will be used to obtain preliminary data in order to proceed with a larger randomized control trial.

Key facts

Study ID

NCT03221764

Run by

University of Louisville

People needed

20

Starts

2017-10-19

Expected to finish

2019-04-01

Last updated by the study team

2020-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject or legal representative has signed Informed Consent Form (ICF)
• Undergoing lung transplant at the Jewish Hospital
• Age ≥ 18 years
• Subjects willing and able to comply with the follow up requirements of the study

You may not qualify if…

• Patients with previous history of atrial fibrillation.
• Patients with previously documented allergy or adverse reaction to amiodarone.
• Patients with previous ablation for atrial fibrillation
• Patients with an implantable pacemaker.

Where it is running

• Jewish Hospital — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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