A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
This study is currently recruiting participants.
Verified July 2013 by VytronUS, Inc.
Information provided by (Responsible Party):
First received: July 9, 2013
Last updated: July 11, 2013
Last verified: July 2013
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by VytronUS, Inc.:
Primary Outcome Measures:
- Device or procedure related adverse events. [ Time Frame: Three months post procedure. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pulmonary vein isolation. [ Time Frame: Three months post procedure. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: VytronUS Ablation System
Treatment with the VytronUS Ablation System.
Device: VytronUS Ablation System
Pulmonary vein isolation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01900678
|Contact: Christopher Schneiderfirstname.lastname@example.org|
|Na Homolce Hospital||Recruiting|
|Prague, Czech Republic|
|Contact: Libor Machalek +420 2 257 252 144 email@example.com|
|Principal Investigator: Petr Neuzil, MD, PhD|
|Principal Investigator: Vivek Reddy, MD|
Sponsors and Collaborators
|Principal Investigator:||Petr Neuzil, MD, PhD||Na Homolce Hospital|