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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with paroxysmal AF with a planned ablation procedure
Exclusion Criteria
- •Prior AF ablation
- •LA size greater than 60mm
- •Mechanical prosthetic MVR
- •Hypertrophic cardiomyopathy
Outcomes
Primary Outcomes
Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
Time Frame: 1 year
Procedural time for pulmonary vein isolation
Time Frame: Index procedure
Secondary Outcomes
- All procedural complications(Index)
- Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure(6 months)
- Quality of life questionnaire(6 months and 1 year)
Investigators
Pier Lambiase
Chief Investigator
University College London Hospitals