HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

CardioFocus

Status and phase: Completed; Phase 3

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: EAS-AC (HeartLight); Procedure: Control Arm Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01456000

25-3002

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

Full description

A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.

Enrollment: 405 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 75 years.
• paroxysmal atrial fibrillation
• failure of at least one AAD
• others

Exclusion criteria

• overall good health as established by multiple criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 2 patient groups

EAS-AC (HeartLight)

Experimental group

Description:

Treatment with the EAS-AC.

Treatment:

Device: EAS-AC (HeartLight)

Control Arm Ablation

Active Comparator group

Description:

Treatment with standard ablation.

Treatment:

Procedure: Control Arm Ablation