Atrial Fibrillation
Conditions
Keywords
Ablation Linear Lesions
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.
Interventions
PROCEDUREPVI
PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.
PROCEDURELA linear ablation
LA linear ablation include mitral isthmus ablation and roof line ablation. Mitral isthmus ablation (from the mitral annulus to the left inferior PV) was performed first, followed by roof line ablation (between the right and left superior PVs).
PROCEDURECFAE ablation
Ablation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms.
PROCEDURElinear ablation
Right atrial CTI ablation was performed during SR.
DEVICECARTO
3 dimensional mapping system
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first documented recurrence of atrial arrhythmias | 2-year follow-up | Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ablation time at ablation | At the end of the first ablation procedure ] | Minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery |
| Fluoroscopy time at ablation | At the end of the first ablation procedure | Minutes of fluoroscopy used during the entire ablation procedure |
| Procedure duration at ablation | At the end of the first ablation procedure | Minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter |
| Type of recurrent arrhythmia | 2-year follow-up | Specific type of recurrent atrial arrhythmia |
| Number of redo procedures | 2-year follow-up | Number of redo procedures，including two or more procedures |
| Complications | 2-year follow-up | Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death. |
Countries
China
Contacts
Primary ContactYuanlong Mr Wang, MD
Outcome results
None listed