CardioFocus HeartLight Post-Approval Study

CardioFocus

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: HeartLight; Procedure: Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03168659

25-3944

Details and patient eligibility

About

This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.

Full description

This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
• failure of at least one anti-arrhythmic drug
• 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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250 participants in 1 patient group

Treatment

Other group

Description:

Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

Treatment:

Procedure: Ablation

Device: HeartLight