Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00678340
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : March 6, 2013
University Hospital Southampton NHS Foundation Trust
The Royal Bournemouth Hospital
Information provided by (Responsible Party):
Pier Lambiase, University College London Hospitals

February 14, 2008
May 15, 2008
March 6, 2013
September 2007
March 2013   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00678340 on Archive Site
  • All procedural complications [ Time Frame: Index ]
  • Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure [ Time Frame: 6 months ]
  • Quality of life questionnaire [ Time Frame: 6 months and 1 year ]
Same as current
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Not Provided
Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation
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

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.

Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Atrial Fibrillation
  • 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.
  • Device: PVAC
    Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
    Other Name: Pulmonary vein ablation catheter, Ablation Frontiers
  • Active Comparator: 1
    WACA and PVI
    Intervention: Device: WACA and PVI
  • Active Comparator: 2
    Intervention: Device: PVAC
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
UCH 07/0094
Not Provided
Not Provided
Pier Lambiase, University College London Hospitals
Pier Lambiase
  • University Hospital Southampton NHS Foundation Trust
  • The Royal Bournemouth Hospital
Principal Investigator: Pier D Lambiase, PhD University College Hospital London NHS Foundation Trust
University College London Hospitals
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP