Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

March 5, 2013 updated by: Pier Lambiase

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • University College Hospital London NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Pulmonary vein ablation catheter, Ablation Frontiers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
Time Frame: 1 year
1 year
Procedural time for pulmonary vein isolation
Time Frame: Index procedure
Index procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
All procedural complications
Time Frame: Index
Index
Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure
Time Frame: 6 months
6 months
Quality of life questionnaire
Time Frame: 6 months and 1 year
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pier Lambiase

Collaborators

University Hospital Southampton NHS Foundation Trust
The Royal Bournemouth Hospital

Investigators

  • Principal Investigator: Pier D Lambiase, PhD, University College Hospital London NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

May 13, 2008

First Posted (Estimate)

May 15, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCH 07/0094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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