High-density Mapping-guided bOx Isolation and subsTrate Ablation

Not Applicable

• Conditions: Atrial Fibrillation; Atrial Remodeling
• Interventions: Procedure: CPVI+BOX+SUB; Procedure: CPVI+BOX; Procedure: CPVI

• Registration Number: NCT03998956
• Lead Sponsor: The Third Xiangya Hospital of Central South University

Brief Summary

This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-01
• Study Start: 2019-08-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Informed consent signed.
• Age of 18 to 75 years old.
• Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
• Willing to have catheter ablation for atrial fibrillation.

Exclusion Criteria

• Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
• Complete atrioventricular block.
• An acute stroke or contradiction of anti-coagulation.
• Hyperthyroidism.
• Having a history of catheter ablation of atrial fibrillation.
• Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
• Pregnancy or lactation.
• Planning for pregnancy in the near future.
• Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
• Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
circumferential PV and BOX isolation with substrate ablation	CPVI+BOX+SUB	Atrial substrate ablation apart from circumferential PV and BOX isolation
Circumferential PV and BOX isolation	CPVI+BOX	Circumferential PV and BOX isolation
Circumferential PV isolation	CPVI	Circumferential PV isolation only

Primary Outcome Measures

Name	Time	Method
sinus rhythm maintenance rate	12 months	Holter is performed 12months after the procedure and heart rhythm is recorded.

Secondary Outcome Measures

Name	Time	Method
left ventricular ejection fraction	12 months	LVEF is evaluated by echocardiography 12months after the procedure.
Stroke or embolic events	12 months	History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed.
Atrial fibrosis	1 day	Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.