BiodEgradable Soaked Amiodarone paTch Use for the Prevent... | NCT06722196

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

NCT06722196

Sponsor

Jilin Heart Hospital

Status

Recruiting

Last Update Posted

Dec 9, 2025Actual

Enrollment

500Estimated

Phase

Phase 3

Conditions

Atrial Fibrillation (AF)

Interventions

topical amiodarone
saline solution patch

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2025Actual

Primary Completion Date

Jan 15, 2027Estimated

Completion Date

Dec 15, 2027Estimated

First Submitted Date

Dec 5, 2024

First Submission Date that Met QC Criteria

Dec 5, 2024

First Posted Date

Dec 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2025

Last Update Posted Date

Dec 9, 2025Actual

Name	Class
Cornell University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
topical amiodarone	Drug	amiodarone soaked patch placed on the left atrial roof at the end of surgery
saline solution patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative atrial fibrillation versus control	incidence of in-hospital atrial fibrillation	within 5 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xin Lu	Contact	+86 13630550809		xin.lu@jlheart.org
Sui C Yu	Contact	+86 17304316969		chunyu.sui@jlheart.org

Overall Officials

Name	Affiliation	Role
Massimo G Lemma, PhD	Jilin Heart Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jilin Heart Hospital	Recruiting	Changchun	Jinlin	130000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000638	Amiodarone

Ancestor Terms

ID	Term
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided