A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).
Age > 18 years; < 80 years
Persistent AF > 1-year duration
Left atrium size < 6cm
Pts should be able to provide written informed consent.
Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments.
Subject has a reversible cause of AF or transient AF
Subject is absent of LAA or if the LAA is previously surgically ligated
Subject has had previous cardiac surgery or abdominal surgery.
Parallel
Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device.
Device2 stage procedure - minimally-invasive epicardial ablation with left atrial appendage exclusion using LARIAT procedure via a subxiphoid incision. This is then combined with endocardial radiofrequency catheter ablation in a separate staged procedure.
Standard Endocardial Catheter Ablation
Procedure/SurgeryStandard percutaneous endocardial catheter ablation of atrial fibrillation
Demonstrate trial feasibility with regards to recruitment rate
Recruitment rate to the Convergent Procedure (with LARIAT) and radiofrequency ablation in the cohort of patients with our specific inclusion criteria will be measured.
A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured.
Primary safety endpoint was a composite of major adverse events (MAE) and complications occurring within 30 days post procedure. Any of the following endpoints counted as a MAE: death, stroke/transient ischaemic attack, myocardial infarction, pericarditis requiring pericardiocentesis or prolongation of hospital stay or readmission, cardiac perforation/tamponade, bleeding at vascular access site requiring intervention, pneumothorax requiring intervention (after removal of chest drain, symptomatic pulmonary vein stenosis \> 70%, permanent phrenic nerve paralysis, atrio-oesophageal fistula, major vascular complications and infection at surgical or puncture site requiring surgical intervention.
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)
Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications
Measure improvement in symptoms following convergent ablation
Measure change in quality of life through the European Heart Rhythm Association (EHRA) patient survey which categorises patients symptoms during physical activity in 4 categories. The higher the class, the greater the severity of symptoms with Class 1 indication no symptoms and Class 4 indicating disabling symptoms with discontinuation of normal daily activity.
Measure improvement in symptoms following convergent ablation.
To measure improvement in quality of life assessment measured through the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire) to be performed at baseline, 6 months and 12 months post procedure. This survey employs the use of 20 questions regarding symptoms, effect on daily activities, treatment concerns and treatment satisfaction to generate a score from 0 - 100. The lower the score, the more severe the disability with score 0 indicating complete disability and score 100 indicating no disability or limitation in daily activities.
Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured.
Assessment of LVEF via transthoracic echocardiogram at baseline and transthoracic echocardiogram at 12 months post procedure.
Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation.
Assessment of heart failure symptoms and functional status via clinic review at baseline and 12 months post-procedure.
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Barts & The London NHS Trust
Lead sponsor
AtriCure, Inc.
Collaborator
