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Completed

NCT Number: NCT04489004

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

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.

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Key information

Conditions

Atrial Fibrillation, Persistent Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, China

About this study

This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Driver ablation+CPVI

Procedure

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

Stepwise ablation

Procedure

Patients receive stepwise ablation.

Primary outcomes

  1. Postoperative atrial fibrillation (AF) recurrence rate

    Time frame: up to 24 months after enrollment

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

  2. Procedural AF termination rate

    Time frame: Before the end of procedure.

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

Secondary outcomes

  1. Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate

    Time frame: up to 24 months after enrollment

    Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.

  2. Incidence of complications

    Time frame: up to 2 weeks after enrollment

    Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 28, 2020
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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