NCT01900678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

July 9, 2013

Last Update Submit

June 26, 2015

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Device or procedure related adverse events.

    Three months post procedure.

Secondary Outcomes (1)

  • Pulmonary vein isolation.

    Three months post procedure.

Study Arms (1)

VytronUS Ablation System

EXPERIMENTAL

Treatment with the VytronUS Ablation System.

Device: VytronUS Ablation System

Interventions

VytronUS Ablation SystemDEVICE

Pulmonary vein isolation.

VytronUS Ablation System

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Na Homolce Hospital

Prague, Czechia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Petr Neuzil, MD, PhD

    Na Homolce Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 16, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations

CZ(1)