A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System

VytronUS

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: VytronUS Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01900678

CIV-13-04-010581 (Registry Identifier)

VLIC-USA

Details and patient eligibility

About

The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.

Enrollment: 7 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 70 years old.
• Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.

Exclusion criteria

• Prior pulmonary vein isolation
• Presence of intracardiac thrombus
• Indication of inaccessible pulmonary or cardiac anatomy
• Myocardial infarction, PCI, or cardiac surgery in prior three months
• Moderate to severe valvular disease or prior valve replacement
• NYHA Class IV
• LVEF < 40%
• Previous stroke or TIA
• Serum creatinine > 2.5mg/dL or allergy to intravenous contrast agents
• Existing bleeding diathesis or history of complications with anticoagulation therapy
• Women who are nursing, pregnant, or trying to become pregnant
• Subjects unwilling or unable to provide consent
• Participation in a drug or device trial that would prevent completion of required study procedures
• Active implantable devices
• Major organ system disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

VytronUS Ablation System

Experimental group

Description:

Treatment with the VytronUS Ablation System.

Treatment:

Device: VytronUS Ablation System