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Prevention of Post-OP AFib Using Combination of CardiaMend and Amiodarone

NCT05681182 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-22

No results posted yet for this 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 isolated cardiac arterial bypass grafting (CABG) or valve surgery.

Conditions

  • Post Operative Atrial Fibrillation

Interventions

COMBINATION_PRODUCT

CardiaMend with the Addition of Amiodarone

The CardiaMend patch will be saturated with Amiodarone prior to being sutured into place.

Sponsors & Collaborators

  • Helios Cardio Inc.

    collaborator INDUSTRY

  • WakeMed Health and Hospitals

    lead OTHER

Principal Investigators

  • Judson B Williams, MD · WakeMed Health and Hospitals

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2024-02-06
Completion
2024-02-06
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681182 on ClinicalTrials.gov