Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Treatments: Amiodarone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.