Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborators:
University Hospital Southampton NHS Foundation Trust.
The Royal Bournemouth Hospital
Information provided by (Responsible Party):
Pier Lambiase, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT00678340
First received: February 14, 2008
Last updated: March 5, 2013
Last verified: March 2013

February 14, 2008
March 5, 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 ] [ Designated as safety issue: No ]
  • Procedural time for pulmonary vein isolation [ Time Frame: Index procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00678340 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
    PVAC
    Intervention: Device: PVAC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00678340
UCH 07/0094
Yes
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