A Randomized Control Study of Catheter Ablation Versus Surgical Ablation as a Treatment in Patients With Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 300
- Primary Endpoint
- Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Study Overview
Brief Summary
This is an open label, randomized parallel control clinical trial evaluating the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Detailed Description
This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into the group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion) and group C (surgical ablation). Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 to 80 years old;
- •Persistent AF with severe atrial fibrosis;
- •Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Exclusion Criteria
- •With uncontrolled congestive heart failure;
- •Having significant valvular disease;
- •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;
- •Having any contraindication to right or left sided heart catheterization;
- •Previous atrial fibrillation ablation;
- •Presence of an implanted cardioverter-defibrillator;
- •Previous history of cardiac surgery;
- •Poor general health;
- •Life expectancy less than 6 months.
Arms & Interventions
Group A
Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
Intervention: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation (Procedure)
Group B
Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
Intervention: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion (Procedure)
Group C
Surgical ablation
Intervention: Surgical ablation (Procedure)
Outcomes
Primary Outcomes
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Time Frame: up to 12 months after enrollment
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Secondary Outcomes
- Postoperative AF recurrence rate(up to 12 months after enrollment)
- Postoperative AFL/AT rate(up to 12 months after enrollment)
- Incidence of complications(up to 12 months after enrollment)
- Changes in the diameter of the left atrium and the left ventricular ejection fraction(up to 12 months after enrollment)
Investigators
Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospital
Shanghai Chest Hospital