Trial Outcomes & Findings for Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients (NCT NCT03221764)

NCT ID: NCT03221764

Last Updated: 2020-06-29

Results Overview

Patient that developed atrial fibrillation after undergoing lung transplantation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Patients will be monitored for up to one year following lung transplant
• Results posted on: 2020-06-29

Participant Flow

Participant milestones

Measure	Study Group Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Study Group n=20 Participants Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
Age, Continuous	64.6 years n=20 Participants
Sex: Female, Male Female	4 Participants n=20 Participants
Sex: Female, Male Male	16 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants
Previous Myocardial Infarction	4 Participants n=20 Participants
Previous Coronary Artery Bypass	1 Participants n=20 Participants
Previous Percutaneous Coronary Intervention	5 Participants n=20 Participants
Diabetes	4 Participants n=20 Participants
Hypertension	12 Participants n=20 Participants
Cerebrovascular Disease	2 Participants n=20 Participants
Smoking History	8 Participants n=20 Participants

PRIMARY outcome

Timeframe: Patients will be monitored for up to one year following lung transplant

Patient that developed atrial fibrillation after undergoing lung transplantation

Outcome measures

Measure	Study Group n=20 Participants Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
Post Operative Atrial Fibrillation	6 Participants

SECONDARY outcome

Timeframe: From transplant to discharge from hospital, up to 1 year

Patients that underwent cardioversion or ablation due to post operative atrial fibrillation

Outcome measures

Measure	Study Group n=20 Participants Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
Atrial Fibrillation Requiring Intervention	3 Participants

SECONDARY outcome

Timeframe: 1 year

Patients that required anti-arrhythmic medication at the time of discharge for post operative atrial fibrillation.

Outcome measures

Measure	Study Group n=20 Participants Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
Anti-Arrhythmic Medication at Discharge	4 Participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Study Group n=20 participants at risk Patients undergoing who underwent application of an amiodarone containing hydrogel at the time of lung transplant.
Cardiac disorders Bradycardia	0.00% 0/20 • 1 Year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Victor van Berkel

University of Louisville

Phone: 502-588-7600

Email: victor.vanberkel@ulp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place