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Clinical Trials in China / NCT06722196
Recruiting Phase 3

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

NCT06722196 · tracked via the Priya Life Science China tracker
Sponsor
Jilin Heart Hospital
Phase
Phase 3
Started
2025-02-15
Last updated
2025-12-09

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

topical amiodaronesaline solution patch

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

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

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

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion Criteria: * All patients who are candidates for elective cardiac surgery trough complete sternotomy with indications of coronary artery disease (both off-pump and on-pump), aortic valve disease, mitral valve disease, tricuspid valve disease, and ascending aorta disease, whether as an isolated pathology or in combination Exclusion Criteria: * patients with a clinical history of atrial or ventricular arrhythmia of any nature and duration, patients undergoing reoperation, patients with emergency surgical indications due to acute myocardial infarction or cardiogenic shock, patients with thyroid disfunction, patients with HOCM and those with pacemakers or ICDs

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Jilin Heart Hospital Changchun Jinlin Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06722196 on ClinicalTrials.gov ↗ ← All trials in China