Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678340
• Other study ID #: UCH 07/0094
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2008
• Last updated: March 5, 2013
• Start date: September 2007
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University College Hospital London NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Pier Lambiase	The Royal Bournemouth Hospital, University Hospital Southampton NHS Foundation Trust.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording		1 year	No
Primary	Procedural time for pulmonary vein isolation		Index procedure	No
Secondary	All procedural complications		Index	Yes
Secondary	Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure		6 months	Yes
Secondary	Quality of life questionnaire		6 months and 1 year	No