Paroxysmal Atrial FibrillationNCT01900678
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
A study testing VytronUS Ablation System in people with Paroxysmal Atrial Fibrillation, run by VytronUS, Inc. at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- VytronUS Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years old.
- Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- VytronUS Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VytronUS Ablation SystemDevice
Pulmonary vein isolation.
| Study group | Role | What they receive |
|---|---|---|
| VytronUS Ablation System | Experimental | Treatment with the VytronUS Ablation System. Receives: Device: VytronUS Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device or procedure related adverse events.
Measured: Three months post procedure.
Secondary outcomes (1)
Pulmonary vein isolation.
Measured: Three months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- VytronUS, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, MD, PhD, Principal investigator, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900678
- Sponsor's protocol ID
- VLIC-USA
- Other IDs
- CIV-13-04-010581
- Status last verified
- Jun 2015
- First submitted
- 9 Jul 2013
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
- ClinicalTrials.gov ID
- NCT01900678
- Acronym / sponsor ID
- VLIC-USA
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- VytronUS, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VytronUS Ablation System | Experimental | Device: VytronUS Ablation SystemTreatment with the VytronUS Ablation System. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 70 years old.
- Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VytronUS Ablation SystemPulmonary vein isolation. | Device | VytronUS Ablation System |
Primary outcome
Device or procedure related adverse events.
Time frame: Three months post procedure.
1 secondary outcome
Pulmonary vein isolation.
Time frame: Three months post procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Neuzil, MD, PhD principal investigator
Na Homolce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VytronUS Ablation System in people with Paroxysmal Atrial Fibrillation, run by VytronUS, Inc. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device or procedure related adverse events. (time frame: Three months post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.