High-density Mapping-guided bOx Isolation and subsTrate Ablation

The Third Xiangya Hospital of Central South University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Atrial Fibrillation Atrial Remodeling

Interventions

CPVIPROCEDURE

Circumferential PV isolation only

CPVI+BOXPROCEDURE

Circumferential PV and BOX isolation

CPVI+BOX+SUBPROCEDURE

Atrial substrate ablation apart from circumferential PV and BOX isolation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

sinus rhythm maintenance rate

Holter is performed 12months after the procedure and heart rhythm is recorded.

Time frame: 12 months

Secondary Outcomes

left ventricular ejection fraction

LVEF is evaluated by echocardiography 12months after the procedure.

Time frame: 12 months

Stroke or embolic events

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.

Time frame: 12 months

Atrial fibrosis

Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.

Time frame: 1 day

Data from ClinicalTrials.gov

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