Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

Pier Lambiase

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: PVAC; Device: WACA and PVI

Study type: Interventional

Funder types: Other

Identifiers

NCT00678340

UCH 07/0094

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

1

Active Comparator group

Description:

WACA and PVI

Treatment:

Device: WACA and PVI

2

Active Comparator group

Description:

PVAC

Treatment:

Device: PVAC