The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.

NCT04489004 | Completed

• 1 other identifier: Credit-AF
• Study Type: interventional
• Target: 1,298
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Conditions

Atrial Fibrillation, Persistent

Keywords

Persistent Atrial Fibrillation; Driver ablation; Stepwise ablation

Outcome Measures

Primary Outcomes (2)

• Postoperative atrial fibrillation (AF) recurrence rate

  AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.

  up to 24 months after enrollment

• Procedural AF termination rate

  AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).

  Before the end of procedure.

Secondary Outcomes (2)

• Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate

  up to 24 months after enrollment

• Incidence of complications

  up to 2 weeks after enrollment

Study Arms (2)

Driver ablation+CPVI

EXPERIMENTAL

Driver ablation plus CPVI (circumferential pulmonary vein isolation)

Procedure: Driver ablation+CPVI

Stepwise ablation

ACTIVE COMPARATOR

Stepwise ablation

Procedure: Stepwise ablation

Interventions

Driver ablation+CPVI PROCEDURE

Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).

Driver ablation+CPVI

Stepwise ablation PROCEDURE

Patients receive stepwise ablation.

Stepwise ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years old;
• Persistent AF;
• nonresponse or intolerance to ≥1 antiarrhythmic drug. -

You may not qualify if:

• With uncontrolled congestive heart failure;
• Having significant valvular disease and/or prosthetic heart valve(s);
• With myocardial infarction or stroke within 6 months of screening;
• With Significant congenital heart disease;
• Ejection fraction was \<40% measured by echocardiography;
• Allergic to contrast media;
• Contraindication to anticoagulation medications;
• Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
• Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
• Having any contraindication to right or left sided heart catheterization;
• Previous atrial fibrillation ablation;
• Presence of an implanted cardioverter-defibrillator;
• Any cardiac surgery within the past 2 months;
• Poor general health;
• Life expectancy less than 6 months.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, deputy director of cardiology department of Shanghai Chest Hospital

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 28, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

CN (1)