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NCT06063538 · ClinicalTrials.gov registry record · Early Phase 1

Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone

A Early Phase 1 study of Atrial Fibrillation and Post-Op Complication, sponsored by University of Chicago.

Recruiting
Registry status
Early Phase 1
Development phase
63
Enrollment target
1
Study location

NCT06063538: Recruiting Early Phase 1 study of Atrial Fibrillation and Post-Op Complication, sponsored by University of Chicago.

NCT06063538 is a Early Phase 1 study of Atrial Fibrillation and Post-Op Complication that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 63 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06063538, a Early Phase 1 study of Atrial Fibrillation and Post-Op Complication, is actively recruiting participants, sponsored by University of Chicago.

RECRUITING
Registry status
Early Phase 1
Development phase
63 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing cardiac arterial bypass grafting (CABG) or valve surgery.

Primary Outcome

The patients have continuous electrocardiogram (EKG) monitoring until discharge to evaluate for any evidence of atrial fibrillation or atrial flutter which lasts longer than one hour or if less than one hour, requires medical or procedural intervention. Evidence of atrial fibrillation or atrial flutter will be confirmed by 12 lead electrocardiogram by loss or changes to the P wave, as well as irregularities in the QRS wave interval, heart rhythm, or rate. If clinically indicated, patients will r

Interventions

  • COMBINATION_PRODUCT CardiaMend in Combination with Amiodarone

Study Locations (1)

Illinois

  • The University of Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2024-02-15
Est. Completion 2027-06
Phase Early Phase 1
University of Chicago

796 total trials

What NCT06063538 shows while recruiting

NCT06063538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which CardiaMend in Combination with Amiodarone is the first listed.

NCT06063538 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT06063538 about?

NCT06063538 is a clinical study titled "Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone". The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing cardiac arterial bypass grafting (CABG) or valve surgery.

What is the current status of trial NCT06063538?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 63 participants. The study started on 2024-02-15. Estimated completion is 2027-06.

What conditions does trial NCT06063538 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Post-Op Complication.

What interventions are being tested in trial NCT06063538?

The interventions under investigation include: CardiaMend in Combination with Amiodarone (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT06063538?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06063538 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Atrial Fibrillation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06063538's enrollment target sits among peer trials

63 163rd of 202 higher than 39 of 202 other Atrial Fibrillation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06063538, the US trial registry maintained by the National Library of Medicine. NCT06063538 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.