Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

NCT ID: NCT00678340

Last Updated: 2013-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

WACA and PVI

Group Type ACTIVE_COMPARATOR

WACA and PVI

Intervention Type DEVICE

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

2

PVAC

Group Type ACTIVE_COMPARATOR

PVAC

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

PVAC

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

Intervention Type DEVICE

Other Intervention Names

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Pulmonary vein ablation catheter, Ablation Frontiers

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role collaborator

The Royal Bournemouth Hospital

OTHER

Sponsor Role collaborator

Pier Lambiase

OTHER

Sponsor Role lead

Responsible Party

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Pier Lambiase

Chief Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pier D Lambiase, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Hospital London NHS Foundation Trust

Locations

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University College Hospital London NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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McCready J, Chow AW, Lowe MD, Segal OR, Ahsan S, de Bono J, Dhaliwal M, Mfuko C, Ng A, Rowland ER, Bradley RJ, Paisey J, Roberts P, Morgan JM, Sandilands A, Yue A, Lambiase PD. Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial. Europace. 2014 Aug;16(8):1145-53. doi: 10.1093/europace/euu064. Epub 2014 May 19.

Reference Type DERIVED
PMID: 24843051 (View on PubMed)

Other Identifiers

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UCH 07/0094

Identifier Type: -

Identifier Source: org_study_id

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