An interventional study of Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. and Standard Endocardial Catheter Ablation in Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent and Atrium; Fibrillation, sponsored by Barts & The London NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Barts & The London NHS Trust · Not applicable, Interventional, and Treatment
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).
Atrial Fibrillation is the commonest arrhythmia and is a major cause of morbidity and mortality, often causative in ischaemic strokes and compounded by heart failure. Treatment options are limited for persistent long-standing AF (PeAF), with pulmonary vein isolation by endocardial ablation being insufficient and further additive endocardial lesions with repeated ablations yield mixed results resultant in further atrial arrhythmias. Currently success rates for catheter ablation are moderate at 40 to 70% in a single procedure.
If this was improved, patient quality of life and readmission rates would significantly improve as well as a reduction in anti-arrhythmic drug use.
The Convergent procedure - is a two stage minimally invasive hybrid approach. The first stage employs surgical ablation to the posterior wall of the left atrium in combination with the LARIAT procedure to isolate the left atrium appendage (LAA). The second stage involves endocardial catheter ablation to confirm the surgical ablation lesions, and perform further endocardial catheter ablation to leverage both epicardial and endocardial lesions to create durable, transmural lesions.
Patients with long-standing persistent AF will be randomised in a 1:1 ratio to either the Convergent ablation with the LARIAT procedure or the standard endocardial catheter ablation.
This feasibility study would assess recruitment to the trial, safety and efficacy of the Convergent procedure, in combination with a left atrial appendage system.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 48 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Barts & The London NHS Trust is the lead sponsor of 151 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Two Staged Convergent AF Ablation Procedure Stage 1 - Minimally Invasive Surgical Epicardial Ablation Procedure with concomitant LAA exclusion (LARIAT procedure) Stage 2 - Percutaneous Endocardial Catheter Ablation
Device: Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. · Procedure: Standard Endocardial Catheter Ablation
Standard Endocardial Catheter Ablation
Procedure: Standard Endocardial Catheter Ablation
2 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 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.
Time frame: 24 months
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.
Time frame: 30 days post procedure
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
Time frame: Measured from the end of a 3 month blanking period to 12 months post procedure
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Nov 2026, 26 months after the start.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 26 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
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