Status:
COMPLETED
The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Atrial Fibrillation, Persistent
Eligibility:
All Genders
18-80 years
Phase:
NA
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 th...
Detailed Description
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+ circumfer...
Eligibility Criteria
Inclusion
- Aged 18 to 80 years old;
- Persistent AF;
- nonresponse or intolerance to ≥1 antiarrhythmic drug. -
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
1298 Patients enrolled
Trial Details
Trial ID
NCT04489004
Start Date
August 1 2020
End Date
December 1 2022
Last Update
February 6 2023
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, China