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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
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Device: WACA and PVI
Device: PVAC
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 178
Study Start Date: September 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
WACA and PVI
 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
PVAC
 Device: PVAC
Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
Other Name: Pulmonary vein ablation catheter, Ablation Frontiers

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678340

Locations
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
Investigators
Principal Investigator: Pier D Lambiase, PhD University College Hospital London NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Pier Lambiase, Chief Investigator, University College London Hospitals
ClinicalTrials.gov Identifier: NCT00678340     History of Changes
Other Study ID Numbers: UCH 07/0094
Study First Received: February 14, 2008
Last Updated: March 5, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013