Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

CardioFocus

Status and phase: Completed; Phase 2

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: CardioFocus HeartLight Endoscopic Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00971204

25-2734

Details and patient eligibility

About

This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 70 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment with HeartLight System

Experimental group

Description:

Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System

Treatment:

Device: CardioFocus HeartLight Endoscopic Ablation System