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OpenTrials
Completed

NCT Number: NCT00678340

Randomized Trial of Two Ablation Catheters in 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University College Hospital London NHS Foundation Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WACA and PVI

Device

Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.

PVAC

Device

Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.

Other names: Pulmonary vein ablation catheter, Ablation Frontiers

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pier Lambiase

Other

Collaborators

  • The Royal Bournemouth Hospital
  • University Hospital Southampton NHS Foundation Trust

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
May 15, 2008
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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