MedTrace Logo

BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery

NCT06722196 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-12-09

No results posted yet for this study

Summary

The primary objective of the present prospective, randomized, double blind, controlled study is to assess whether the application of 2 oxidized regenerated cellulose (SurgicelTM FibrillarTM) patches soaked with amiodarone hydrochloride over the anterior wall of the left atrium and the lateral wall of the right atrium results in a reduction in the incidence of POAF

Conditions

  • Atrial Fibrillation (AF)

Interventions

DRUG

topical amiodarone

amiodarone soaked patch placed on the left atrial roof at the end of surgery

OTHER

saline solution patch

saline solution soaked patch placed on left atrial roof at the end of surgery

Sponsors & Collaborators

Principal Investigators

  • Massimo G Lemma, PhD · Jilin Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2027-01-15
Completion
2027-12-15

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT06722196 on ClinicalTrials.gov