A Single-arm Study to Evaluate the Efficacy and Safety of Left Atrial Isolation Achieved by Catheter Ablation in Patients With Persistent Atrial Fibrillation and Severe Atrial Fibrosis: a Chinese Registry Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 50
- Primary Endpoint
- Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Detailed Description
This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Investigators
Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospital
Shanghai Chest Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged 18 to 80 years old
- •Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter \> 50mm
- •Nonresponse or intolerance to ≥1 antiarrhythmic drug
- •CHA2DS2-VASc ≥ 3 and HAS-BLED \< 3
Exclusion Criteria
- •With uncontrolled congestive heart failure;
- •Having significant valvular disease;
- •Having moderate-to-severe pulmonary hypertension;
- •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 thrombus;
Outcomes
Primary Outcomes
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Time Frame: up to 18 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 AFL/AT rate(up to 18 months after enrollment)
- Postoperative AF recurrence rate(up to 18 months after enrollment)
- Incidence of complications(up to 18 months after enrollment)
- Changes in the diameter of the left atrium and the left ventricular ejection fraction(up to 18 months after enrollment)