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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900678
• Other study ID #: VLIC-USA
• Secondary ID: CIV-13-04-010581
• Status: Completed
• Phase: N/A
• First received: July 9, 2013
• Last updated: June 26, 2015
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: VytronUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• VytronUS Ablation System
Pulmonary vein isolation.

Locations

Country	Name	City	State
Czech Republic	Na Homolce Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
VytronUS, Inc.

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device or procedure related adverse events.		Three months post procedure.	Yes
Secondary	Pulmonary vein isolation.		Three months post procedure.	No