Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: WACA and PVI; Device: PVAC

• Registration Number: NCT00678340
• Lead Sponsor: Pier Lambiase

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-05-13
• Study First Posted: 2008-05-15
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	WACA and PVI	WACA and PVI
2	PVAC	PVAC

Primary Outcome Measures

Name	Time	Method
Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording	1 year
Procedural time for pulmonary vein isolation	Index procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College Hospital London NHS Foundation Trust; 🇬🇧 London, United Kingdom