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

NCT06722196 | Recruiting Phase 3 DMC

• 1 other identifier: Jilin Heart Hospital 2024
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• postoperative atrial fibrillation versus control

  incidence of in-hospital atrial fibrillation

  within 5 days after surgery

Study Arms (2)

Experimental

EXPERIMENTAL

patients will receive 2 patches soaked in cordarone hydrochloride (150 mg/3 ml each)

Sham

SHAM COMPARATOR

patients will receive 2 patches soaked in saline solution (3 ml each)

Interventions

topical amiodarone DRUG

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

saline solution patch OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jilin Heart Hospital: lead
• Cornell University: collaborator

Study Sites (1)

Jilin Heart Hospital

Changchun, Jinlin, 130000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Massimo G Lemma, PhD

  Jilin Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Lu

CONTACT

+86 13630550809; xin.lu@jlheart.org

Sui C Yu

CONTACT

+86 17304316969; chunyu.sui@jlheart.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: February 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)