Optimal Ablation Endpoint for Longstanding Persistent Atrial Fibrillation: a Randomized Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Time to first documented recurrence of atrial arrhythmias
Study Overview
Brief Summary
This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.
Detailed Description
Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE ablation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with longstanding persistent atrial fibrillation (lasting for>1 year)
- •Exhibited refractoriness to at least one antiarrhythmic drug
- •Left atrial diameter <=60mm
Exclusion Criteria
- •Patients 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 warfarin or heparin
- •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
- •Poor general health
- •Life expectancy less than 6 months
Arms & Interventions
PVI+LA linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
Intervention: PVI (Procedure)
PVI+CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.
Intervention: PVI (Procedure)
PVI+LA linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
Intervention: LA linear ablation (Procedure)
PVI+LA linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
Intervention: CFAE ablation (Procedure)
PVI+LA linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI, LA linear ablation (roof line and mitral isthmus)and CFAE ablation.
Intervention: CARTO (Device)
PVI+linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
Intervention: PVI (Procedure)
PVI+linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
Intervention: LA linear ablation (Procedure)
PVI+linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
Intervention: CFAE ablation (Procedure)
PVI+linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
Intervention: linear ablation (Procedure)
PVI+linear ablation +CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI,roof line and mitral isthmus,cavotricuspid isthmus abaltion and CFAE ablation.
Intervention: CARTO (Device)
PVI+CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.
Intervention: CFAE ablation (Procedure)
PVI+CFAE ablation
The ablation procedure for atrial fibrillation guided by CARTO system, including PVI and CFAE ablation.
Intervention: CARTO (Device)
Outcomes
Primary Outcomes
Time to first documented recurrence of atrial arrhythmias
Time Frame: 2-year follow-up
Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure
Secondary Outcomes
- Number of redo procedures(2-year follow-up)
- Procedure duration at ablation(At the end of the first ablation procedure)
- Ablation time at ablation(At the end of the first ablation procedure ])
- Fluoroscopy time at ablation(At the end of the first ablation procedure)
- Complications(2-year follow-up)
- Type of recurrent arrhythmia(2-year follow-up)
Investigators
wang yuanlong
MD
Shanghai Chest Hospital