Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation
Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes.
Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF.
The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation.
The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Single Centre, Randomized, Single Blinded Trial of Wide Area Circumferential Ablation With Pulmonary Vein Isolation Compared to a Multipolar, Circular Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation|
- Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Procedural time for pulmonary vein isolation [ Time Frame: Index procedure ] [ Designated as safety issue: No ]
- All procedural complications [ Time Frame: Index ] [ Designated as safety issue: Yes ]
- Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Quality of life questionnaire [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 1
WACA and PVI
Device: WACA and PVI
Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.
Active Comparator: 2
Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
Other Name: Pulmonary vein ablation catheter, Ablation Frontiers
|University College Hospital London NHS Foundation Trust|
|London, United Kingdom|
|Principal Investigator:||Pier D Lambiase, PhD||University College Hospital London NHS Foundation Trust|