Phase 2
N=20
Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients
Atrial Fibrillation · Lung Transplant; Complications
Bottom Line
View on ClinicalTrials.gov: NCT03221764 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Post Operative Atrial Fibrillation — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Amiodarone with CoSeal (Drug); CO2 driver (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Atrial Fibrillation |
6 | — |
| SECONDARY Atrial Fibrillation Requiring Intervention |
3 | — |
| SECONDARY Anti-Arrhythmic Medication at Discharge |
4 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03221764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.