A Study of the Safety and Efficacy of the VytronUS Low-In... | NCT01900678

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

NCT01900678

Sponsor

VytronUS, Inc.

Status

Completed

Last Update Posted

Jun 29, 2015Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Paroxysmal Atrial Fibrillation

Interventions

VytronUS Ablation System

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIV-13-04-010581	Registry Identifier	EUDAMED

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jul 9, 2013

First Submission Date that Met QC Criteria

Jul 11, 2013

First Posted Date

Jul 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2015

Last Update Posted Date

Jun 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VytronUS Ablation System	Experimental	Treatment with the VytronUS Ablation System.	Device: VytronUS Ablation System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VytronUS Ablation System	Device	Pulmonary vein isolation.	VytronUS Ablation System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Device or procedure related adverse events.		Three months post procedure.

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary vein isolation.		Three months post procedure.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petr Neuzil, MD, PhD	Na Homolce Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Na Homolce Hospital		Prague			Czechia

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided