Clinical trial NCT00678340: Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Randomized Controlled Trial
Single-Blind Study
Catheter Ablation
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: University Hospital Southampton NHS Foundation Trust
name: The Royal Bournemouth Hospital
First posted: 2008-05-15
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
timeFrame: 1 year
measure: Procedural time for pulmonary vein isolation
timeFrame: Index procedure
Secondary outcomes:
measure: All procedural complications
timeFrame: Index
measure: Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure
timeFrame: 6 months
measure: Quality of life questionnaire
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College Hospital London NHS Foundation Trust
Study officials:
affiliation: University College Hospital London NHS Foundation Trust
name: Pier D Lambiase, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCready J, Chow AW, Lowe MD, Segal OR, Ahsan S, de Bono J, Dhaliwal M, Mfuko C, Ng A, Rowland ER, Bradley RJ, Paisey J, Roberts P, Morgan JM, Sandilands A, Yue A, Lambiase PD. Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial. Europace. 2014 Aug;16(8):1145-53. doi: 10.1093/europace/euu064. Epub 2014 May 19.