Paroxysmal Atrial FibrillationVALUENCT03639597
Clinical Investigation of the VytronUS Ablation System for Treatment of 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
The study is a single center, open-label, single arm, prospective pre-market study designed to assess the safety and efficacy of the VytronUS Ablation System (VAS) for the treatment of atrial fibrillation in patients with drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation. 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
- 53 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Jan 2016to Dec 2018
- 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:
- a.Episodes of AF i.≥2 recurrent AF episodes of more than 30 seconds' duration that self-terminate and lasting no more than 7 continuous days or ii.Episodes of AF ≤ 48 hours duration terminated with electrical or pharmacologic cardioversion count as a paroxysmal atrial fibrillation episode b.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
- Non-paroxysmal AF (e.g. persistent, long-standing persistent, or permanent AF)
- AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
- Prior LA ablation or surgery
- Women known to be pregnant or breastfeeding or of childbearing potential unless on satisfactory contraceptive routine
- NYHA Class III or IV congestive heart disease
- LVEF <40% measured by acceptable cardiac testing (eg. TTE, TEE)
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- Anteroposterior LA diameter >5.5cm or <3.0cm by TTE
- 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
- Presence of a cardiac valve prosthesis
- Bleeding diathesis or contraindication to anticoagulation therapy
- Blood clotting abnormalities (genetic)
- MI, PCI, invasive cardiac procedure or surgery within 90 days prior to the index ablation procedure
- Previous CVA, TIA, or PE within 3 months prior to the index procedure
- Structural heart defect that, in the investigator's opinion, prevents catheter access or increases risk of ablation procedure
- Pacemaker, ICD, or CRT implantation within 6 months prior to the index ablation procedure
- Active systemic infection
- Subject contraindicated for both MRI and CT
- Life expectancy less than 360 days in physician's opinion
- Participation in a drug or device study
- Exclusion as per local laws -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation - The VALUE Study
The study is a single center, open-label, single arm, prospective pre-market study designed to assess the safety and efficacy of the VytronUS Ablation System (VAS) for the treatment of atrial fibrillation in patients with drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
Read the detailed description
Subjects with documented symptomatic, recurrent, PAF refractory to at least one beta blocker, calcium channel blocker or Class I or Class III anti-arrhythmic drug, who meet all inclusion/exclusion criteria and are deemed appropriate candidates for catheter ablation will undergo PV ablation with the VAS. Pre-procedural CT scan or MRI will be obtained to assess LA and PV anatomy and size. PV ablation will be performed utilizing the VAS (see procedure description below). Acute post-ablation confirmation of PV electrical isolation will be evaluated via standard mapping techniques.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- VytronUS Ablation System
- Keywords
- ablation, ultrasound, automation, catheter
- 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
| 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 Efficacy - Acute success and chronic freedom from AF, AFL and AT lasting longer than 30 seconds, freedom from new class I or II AAD
Acute (or technical) procedural success defined as PVI documented by confirmed entrance block. Chronic success defined by freedom from symptomatic AF, AT and AFL lasting longer than 30 seconds, freedom from new class I or II AAD and no repeat ablation through 12 months of follow-up.
Measured: 12 months
Primary Safety - incidence of acute AEs occurring within 7 days of procedure and chronic adverse events
Acute major AEs occurring within 7 days of procedure and chronic AEs defined as symptomatic PV stenosis >70% or symptomatic atrio-esophageal fistula diagnosed within 12 months.
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 posted21 Aug 2018
- Study start18 Jan 2016
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- VytronUS, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639597
- Sponsor's protocol ID
- 980-06114-00
- Acronym
- VALUE
- Status last verified
- Apr 2019
- First submitted
- 17 Jul 2018
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turagam MK, Petru J, Neuzil P, Kakita K, Kralovec S, Harari D, Phillips P, Piazza D, Whang W, Dukkipati SR, Reddy VY. Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial. Circ Arrhythm Electrophysiol. 2020 Mar;13(3):e007917. doi: 10.1161/CIRCEP.119.007917. Epub 2020 Feb 12.
PubMed 32078362
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. 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 Paroxysmal Atrial Fibrillation - The VALUE Study
- ClinicalTrials.gov ID
- NCT03639597
- Acronym / sponsor ID
- VALUE / 980-06114-00
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- ablation, ultrasound, automation, catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- VytronUS, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Aug 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.
The study is a single center, open-label, single arm, prospective pre-market study designed to assess the safety and efficacy of the VytronUS Ablation System (VAS) for the treatment of atrial fibrillation in patients with drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
Detailed description
Subjects with documented symptomatic, recurrent, PAF refractory to at least one beta blocker, calcium channel blocker or Class I or Class III anti-arrhythmic drug, who meet all inclusion/exclusion criteria and are deemed appropriate candidates for catheter ablation will undergo PV ablation with the VAS. Pre-procedural CT scan or MRI will be obtained to assess LA and PV anatomy and size. PV ablation will be performed utilizing the VAS (see procedure description below). Acute post-ablation confirmation of PV electrical isolation will be evaluated via standard mapping techniques.
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 (7 listed)
- Age between 18 and 75 years
- History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by:
- a.Episodes of AF i.≥2 recurrent AF episodes of more than 30 seconds' duration that self-terminate and lasting no more than 7 continuous days or ii.Episodes of AF ≤ 48 hours duration terminated with electrical or pharmacologic cardioversion count as a paroxysmal atrial fibrillation episode b.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.
Key exclusion criteria (22 listed)
- Non-paroxysmal AF (e.g. persistent, long-standing persistent, or permanent AF)
- AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
- Prior LA ablation or surgery
- Women known to be pregnant or breastfeeding or of childbearing potential unless on satisfactory contraceptive routine
- NYHA Class III or IV congestive 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 System | Device | Study device |
Primary outcome
Primary Efficacy - Acute success and chronic freedom from AF, AFL and AT lasting longer than 30 seconds, freedom from new class I or II AAD
Time frame: 12 months
Acute (or technical) procedural success defined as PVI documented by confirmed entrance block. Chronic success defined by freedom from symptomatic AF, AT and AFL lasting longer than 30 seconds, freedom from new class I or II AAD and no repeat ablation through 12 months of follow-up.
Primary Safety - incidence of acute AEs occurring within 7 days of procedure and chronic adverse events
Time frame: 12 months
Acute major AEs occurring within 7 days of procedure and chronic AEs defined as symptomatic PV stenosis >70% or symptomatic atrio-esophageal fistula diagnosed within 12 months.
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 24 Apr 2019.
- Derived from this study: PubMed 32078362Turagam MK, Petru J, Neuzil P, Kakita K, Kralovec S, Harari D, Phillips P, Piazza D, Whang W, Dukkipati SR, Reddy VY. Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial. Circ Arrhythm Electrophysiol. 2020 Mar;13(3):e007917. doi: 10.1161/CIRCEP.119.007917. Epub 2020 Feb 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 7 inclusion and 22 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 24 Apr 2019. 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?
Primary Efficacy - Acute success and chronic freedom from AF, AFL and AT lasting longer than 30 seconds, freedom from new class I or II AAD (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT03639597, which also lists 1 linked publication.
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 24 Apr 2019.