Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00678340

Enrollment

178

Registered

2008-05-15

Start date

2007-09-30

Completion date

2013-03-31

Last updated

2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Randomized Controlled Trial, Single-Blind Study, Catheter Ablation

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.

Interventions

DEVICEWACA and PVI

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

DEVICEPVAC

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026