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Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

NCT00678340 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2013-03-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • The Royal Bournemouth Hospital

    collaborator OTHER

  • Pier Lambiase

    lead OTHER

Principal Investigators

  • Pier D Lambiase, PhD · University College Hospital London NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00678340 on ClinicalTrials.gov