Paroxysmal Atrial FibrillationVITALNCT03513029
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
A study testing VytronUS Ablation System in people with Paroxysmal Atrial Fibrillation, run by VytronUS, Inc. at 1 site in Czechia.
Trial summary
VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low intensity collimated ultrasound (LICU) for imaging and ablation. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Jan 2018to Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by:
- Two or more symptomatic AF episodes lasting greater than 30 seconds duration that self-terminate and lasting no more than 7 continuous days. An episode of AF ≤ 48 hours duration terminated with electrical or pharmacologic cardioversion counts as a paroxysmal atrial fibrillation episode.
- At least one episode of paroxysmal atrial fibrillation (PAF) documented on 12-lead ECG, event monitor, or telemetry monitor in the prior year
- Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD).
- Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice.
- Subject is able and willing to give informed consent.
- Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study
Who cannot join
- Prior LA ablation or surgery
- Persistent, longstanding persistent, or permanent AF
- AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
- NYHA Class III or IV congestive heart failure
- Rheumatic heart disease
- Atrial myxoma
Show all 12Show fewer
- LVEF <40% measured by acceptable cardiac testing (e.g. TTE, TEE)
- Anteroposterior LA diameter >5.5cm or <3.5cm by TTE, CT or MRI
- Presence of intracardiac thrombus (including a known history of thrombus) within 30 days prior to the index ablation procedure
- Presence of pulmonary vein stent(s)
- Presence of pre-existing pulmonary narrowing or pulmonary vein stenosis greater than 70%
- Presence of pre-existing pericardial effusion
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Na Homolce
Prague
Study coordinator, Katerina.Mzourkova@homolka.cz
About this study
VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low intensity collimated ultrasound (LICU) for imaging and ablation.
Read the detailed description
Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated consistent with the 2012 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Expert Consensus Statement on Catheter and Surgical Ablation for Atrial Fibrillation. Eligible patients will receive treatment with the VAS including ultrasound imaging of the left atrium and cardiac ablation to electrically isolate the pulmonary veins.
Up to 100 patients will be enrolled at up to 10 sites in Europe (EU) and in the United States (US).
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- VytronUS Ablation System
- Keywords
- PAF, atrial fibrillation, ablation, low intensity collimated ultrasound
- 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
Catheter Ablation for Paroxysmal Atrial Fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Study Device | Experimental | 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.
Primary Safety: Incidence of early-onset serious adverse events
Incidence of early-onset serious adverse events
Measured: 7 days or discharge, whichever is sooner
Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT
Acute success and chronic freedom from AF, AFL or AT
Measured: 12 months
Secondary outcomes (1)
Secondary Safety: All serious adverse events
All serious adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start20 Jan 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VytronUS, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513029
- Sponsor's protocol ID
- 980-08694-00
- Acronym
- VITAL
- Status last verified
- Apr 2018
- First submitted
- 27 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03513029
- Acronym / sponsor ID
- VITAL / 980-08694-00
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- PAF, atrial fibrillation, ablation, low intensity collimated ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VytronUS, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 May 2018 (actual)
- 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.
VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low intensity collimated ultrasound (LICU) for imaging and ablation.
Detailed description
Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated consistent with the 2012 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Expert Consensus Statement on Catheter and Surgical Ablation for Atrial Fibrillation. Eligible patients will receive treatment with the VAS including ultrasound imaging of the left atrium and cardiac ablation to electrically isolate the pulmonary veins.
Up to 100 patients will be enrolled at up to 10 sites in Europe (EU) and in the United States (US).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Device | Experimental | Device: VytronUS Ablation SystemVytronUS Ablation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 75 years
- History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by:
- Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD).
- Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice.
- Subject is able and willing to give informed consent.
Key exclusion criteria (12 listed)
- Prior LA ablation or surgery
- Persistent, longstanding persistent, or permanent AF
- AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
- NYHA Class III or IV congestive heart failure
- Rheumatic heart disease
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 SystemCatheter Ablation for Paroxysmal Atrial Fibrillation | Device | Study Device |
Primary outcome
Primary Safety: Incidence of early-onset serious adverse events
Time frame: 7 days or discharge, whichever is sooner
Incidence of early-onset serious adverse events
Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT
Time frame: 12 months
Acute success and chronic freedom from AF, AFL or AT
1 secondary outcome
Secondary Safety: All serious adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: No
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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.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Director Clinical Affairs (+1 408 730 1333, davidh@vytronus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety: Incidence of early-onset serious adverse events (time frame: 7 days or discharge, whichever is sooner). The study lists 2 primary outcomes in all. 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 1 May 2018.