An interventional study of Thoracoscopically Assisted Surgical Ablation and Catheter Ablation in Persistent Atrial Fibrillation, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-30.
Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Not applicable, Interventional, and Treatment
Atrial fibrillation(AF)is the commonest arrhythmia worldwide and can lead to significant morbidity and mortality, posing an increasing public health burden. Restoration of sinus rhythm (SR) is the preferred strategy in symptomatic patients but outcomes with anti-arrhythmic drugs (AAD) are poor. The alternatives to AAD are two-fold.Firstly, catheter ablation (CA)- a technique that uses catheters (thin tubes) to deliver small 'heat lesions' to areas of the heart to eliminate AF. Secondly, surgical ablation, where multiple incisions are made in the atria to restore SR. Long term results from this traditional surgical approach are excellent however as it is technically difficult open-heart procedure with significant morbidity and mortality, it is seldom used.
CA is very effective in restoring SR in the early stages of AF when it is a paroxysmal (intermittent) rhythm disturbance. If not treated at this stage AF inevitably evolves into a more persistent or permanent state and becomes more difficult to treat with CA. Therefore, the optimum approach to treat patients with symptomatic long standing persistent AF has yet to be determined and remains a key area of on-going research.
New minimally invasive, thoracoscopically assisted surgical(closed-heart)approaches have recently developed which ablate a wide area around the pulmonary veins, and may offer advantages over the best current strategies in CA. There are also clear advantages for patients with greater safety and less discomfort when compared to traditional surgical open-heart procedures.
At present there is small amount of encouraging data on this thoracoscopic surgical technique but there is no data comparing these two modalities of treatment in persistent AF patients. The investigators therefore wish to prospectively investigate the safety and efficacy of this thoracoscopic surgical technique and compare with CA in this group of patients. MRI scanning will also be used to visualise the effects of ablation by analysis of scar formation.
The study hypothesises that thoracoscopics surgical ablation is a
This will be a pilot, prospective, observational study of catheter ablation compared with thoracoscopically assisted, surgical ablation strategies using a case control design.
The study population will be patients between the ages of 18 and 80 with symptomatic long-standing persistent atrial fibrillation (≥1≤5 years) and good left ventricular function where at least one anti-arrhythmic drug (AAD) has failed, or where such drugs are contraindicated or not tolerated.
Thoracoscopically Assisted Surgical Ablation Group Patients assigned to this group will undergo minimally invasive, thoracoscopically assisted, surgical ablation to isolate the pulmonary veins (PVI) using a radiofrequency (RF) clamp device. This will include ganglionated plexi ablation +/- LAA excision/exclusion.
Catheter Ablation Group Patients will undergo pulmonary vein isolation, linear and electrogram based ablation.
Recurrences Only one redo procedure is allowed for atrial tachyarrhythmia recurrences in the 12 month follow-up period.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 60 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm will have an index thoracoscopically assisted surgical ablation.
Procedure: Thoracoscopically Assisted Surgical Ablation
This is an active comparator arm where study subjects will undergo conventional catheter ablation.
Procedure: Catheter Ablation
Surgical AF ablation including pulmonary vein isolation, gananglionated plexi ablation +/- LAA excision/exclusion.
In this arm, study subjects will undergo conventional catheter ablation as their index procedure. This will include pulmonary vein isolation, linear and electrogram based ablation.
Freedom from atrial tachyarrhythmias at 12 months.
Freedom from atrial tachyarrhythmias at 12 months which will be analysed with or without anti-arrhythmic drugs (AAD). Monitoring will be undertaken with ambulatory ECG monitoring in compliance with latest international guidelines.
Time frame: 12 months
Freedom from atrial tachyarrhythmias at 12 months from a single procedure on/off AAD;
Only 1 re-do procedure is allowed in study time frame. But this outcome will look at single procedure success in both arms at 12 months.
Time frame: 12 months
Change in AF symptom score
Using recognised AF symptom score scale
Time frame: Various time points 0,3,6,9,12 months
Integrity of ablation lesion after index procedure at 3 months (as assessed by MRI if in SR +/- electrophysiologically if redo procedure is undertaken for atrial arrhythmia recurrence);
Using MRI +/- electrophysiological techniques.
Time frame: 3 months
Freedom of serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up.
Time frame: 12 months
Cost analysis (procedural and hospital stay costs).
Top down cost analysis
Time frame: 12 months
This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Royal Brompton & Harefield NHS Foundation Trust