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NCT03221764 · ClinicalTrials.gov registry record · Phase 2

Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients

A Phase 2 study, sponsored by University of Louisville.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT03221764 is a Phase 2 study that has completed, run by University of Louisville. The registered enrollment target is 20 participants.

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The verdict

NCT03221764, a Phase 2 study, has completed, sponsored by University of Louisville.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study 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.

Interventions

  • DRUG Amiodarone with CoSeal
  • DEVICE CO2 driver

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-10-19
Est. Completion 2019-04-01
Phase Phase 2

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT03221764

The ClinicalTrials.gov registry entry for NCT03221764 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Amiodarone with CoSeal is the first listed.

NCT03221764 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03221764 about?

NCT03221764 is a clinical study titled "Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients". 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 ...

What is the current status of trial NCT03221764?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2017-10-19. Estimated completion is 2019-04-01.

What interventions are being tested in trial NCT03221764?

The interventions under investigation include: Amiodarone with CoSeal (DRUG), CO2 driver (DEVICE).

Who is sponsoring clinical trial NCT03221764?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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