Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation

Not Applicable

Recruiting

• Conditions: Persistent Atrial Fibrillation; Fibrillation; Atrial Fibrillation, Persistent; Atrium; Atrial Arrhythmia

• Registration Number: NCT06165510
• Lead Sponsor: Barts & The London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Age > 18 years; < 80 years<br><br> - Persistent AF > 1-year duration<br><br> - Left atrium size < 6cm<br><br> - Pts should be able to provide written informed consent.<br><br>Exclusion Criteria:<br><br> - Subjects currently enrolled in another investigational study except in case of<br> observational registry with no associated treatments.<br><br> - Subject has a reversible cause of AF or transient AF<br><br> - Subject is absent of LAA or if the LAA is previously surgically ligated<br><br> - Subject has had previous cardiac surgery or abdominal surgery.<br><br> - Subject has contraindication to anticoagulation.<br><br> - Patients with hypertrophic cardiomyopathy.<br><br> - Patients with significant valve disease.<br><br> - Subject has had previous catheter or surgical ablation

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate trial feasibility with regards to recruitment rate;A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured.;Success or failure at 12 months of persistent AF patients to be free of: Atrial arrhythmia (classed as documentation of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds);Measure improvement in symptoms following convergent ablation

Secondary Outcome Measures

Name	Time	Method
Measure improvement in symptoms following convergent ablation.;Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured.;Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation.