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

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: WACA and PVI Device: PVAC Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
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
Device: PVAC
Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
Other Name: Pulmonary vein ablation catheter, Ablation Frontiers

Primary Outcome Measures :
  1. Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording [ Time Frame: 1 year ]
  2. Procedural time for pulmonary vein isolation [ Time Frame: Index procedure ]

Secondary Outcome Measures :
  1. All procedural complications [ Time Frame: Index ]
  2. Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure [ Time Frame: 6 months ]
  3. Quality of life questionnaire [ Time Frame: 6 months and 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00678340

United Kingdom
University College Hospital London NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pier Lambiase, Chief Investigator, University College London Hospitals Identifier: NCT00678340     History of Changes
Other Study ID Numbers: UCH 07/0094
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by Pier Lambiase, University College London Hospitals:
Randomized Controlled Trial
Single-Blind Study
Catheter Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes