High-density Mapping-guided bOx Isolation and subsTrate Ablation

NCT ID: NCT03998956

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-08-31

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.

Conditions

Atrial Fibrillation; Atrial Remodeling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Circumferential PV isolation

Circumferential PV isolation only

Group Type: ACTIVE_COMPARATOR

CPVI

Intervention Type: PROCEDURE

Circumferential PV isolation only

Circumferential PV and BOX isolation

Circumferential PV and BOX isolation

Group Type: EXPERIMENTAL

CPVI+BOX

Intervention Type: PROCEDURE

Circumferential PV and BOX isolation

circumferential PV and BOX isolation with substrate ablation

Atrial substrate ablation apart from circumferential PV and BOX isolation

Group Type: EXPERIMENTAL

CPVI+BOX+SUB

Intervention Type: PROCEDURE

Atrial substrate ablation apart from circumferential PV and BOX isolation

Interventions

CPVI

Circumferential PV isolation only

Intervention Type: PROCEDURE

CPVI+BOX

Circumferential PV and BOX isolation

Intervention Type: PROCEDURE

CPVI+BOX+SUB

Atrial substrate ablation apart from circumferential PV and BOX isolation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

3rdxiangya@csu

Identifier Type: -

Identifier Source: org_study_id