Atrial FibrillationPhase 3VERSATILENCT01656772
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
A Phase 3 study testing Vdrive Lasso navigation and Manual Lasso navigation in people with Atrial Fibrillation, run by Stereotaxis at 5 sites in 3 countries.
Trial summary
This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vdrive Lasso navigation and Manual Lasso navigation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left atrial AF ablation procedure requiring the use of a Lasso mapping catheter
- Subject must be at least 18 years of age
- Subject must be male, female of no childbearing potential, or a female that has a negative pregnancy test prior to randomization
Who cannot join
- Unable to safely expose subject to a magnetic field
- Prior AF ablation procedure
- Patients with fewer than 4 PVs are excluded
- Patients with persistent AF in whom early recurrence of AF following cardioversion would preclude completion of the pacing maneuvers described in the protocol or patients with other conditions that would similarly preclude completion of the pacing maneuvers
- Contraindication to procedure or unable to return for follow-up
- History of clotting disorder, bleeding abnormalities or contraindication to anticoagulation
Show all 12Show fewer
- Actively participating in other cardiac device trial(s)
- Currently pregnant
- Under 18 years of age
- Prosthetic valves
- Atrial abnormalities (thrombus, myxoma or baffle)
- Other exclusions per the investigator
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78705
Baylor Research Institute
Dallas, Texas, 75204
Central Baptist Hospital
Lexington, Kentucky, 40503
About this study
This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures.
Read the detailed description
Key to the success of an electrophysiology procedure is the ability to accurately map, sense and pace the heart. Electrophysiology mapping catheters are available in a variety of shapes and electrode configurations. The majority of these catheters are manipulated manually by the physician. The Vdrive simplifies these manipulations by allowing an operator to mechanically advance, retract, rotate, deflect and maneuver a circular mapping catheter. The circular mapping catheter is not altered in structure, function or indication in the same manner as the predicate device (Cardiodrive Catheter Advancement System).
This is a prospective, randomized, non-blinded, controlled study comparing manual navigation of a circular mapping catheter with mechanical navigation by the Vdrive. A total of 120 patients are expected to complete the study: 80 patients in the Vdrive navigation arm and 40 patients in the manual navigation arm. Patients will be enrolled at a minimum of one site in the European Union where the product is currently marketed and the United States, where the Vdrive is considered to be investigational.
- Conditions
- Atrial Fibrillation
- Being tested
- Vdrive Lasso navigation, Manual Lasso navigation
- Keywords
- magnetic navigation, robotic control, RMT ThermoCool 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.
Vdrive Lasso navigationDevice
Remote robotic Lasso navigation
Manual Lasso navigationProcedure or surgery
Manually maneuver a Lasso catheter
| Study group | Role | What they receive |
|---|---|---|
| Manual Lasso navigation | Active comparator | Use of conventional manual navigation techniques with the Lasso catheter Receives: Procedure: Manual Lasso navigation |
| Vdrive Lasso navigation | Experimental | Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Receives: Device: Vdrive Lasso navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.
Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05.
Measured: Peri-procedural
Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.
The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.
Measured: 7 days Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qun Sha, MD, Study director, Stereotaxis Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656772
- Sponsor's protocol ID
- CLIN-020
- Acronym
- VERSATILE
- Status last verified
- Jun 2015
- First submitted
- 30 Jul 2012
- Last updated
- 1 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
- ClinicalTrials.gov ID
- NCT01656772
- Acronym / sponsor ID
- VERSATILE / CLIN-020
- Conditions
- Atrial Fibrillation
- Keywords
- magnetic navigation, robotic control, RMT ThermoCool catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Posted 4 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures.
Detailed description
Key to the success of an electrophysiology procedure is the ability to accurately map, sense and pace the heart. Electrophysiology mapping catheters are available in a variety of shapes and electrode configurations. The majority of these catheters are manipulated manually by the physician. The Vdrive simplifies these manipulations by allowing an operator to mechanically advance, retract, rotate, deflect and maneuver a circular mapping catheter. The circular mapping catheter is not altered in structure, function or indication in the same manner as the predicate device (Cardiodrive Catheter Advancement System).
This is a prospective, randomized, non-blinded, controlled study comparing manual navigation of a circular mapping catheter with mechanical navigation by the Vdrive. A total of 120 patients are expected to complete the study: 80 patients in the Vdrive navigation arm and 40 patients in the manual navigation arm. Patients will be enrolled at a minimum of one site in the European Union where the product is currently marketed and the United States, where the Vdrive is considered to be investigational.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Lasso navigation | Active comparator | Procedure: Manual Lasso navigationUse of conventional manual navigation techniques with the Lasso catheter |
| Vdrive Lasso navigation | Experimental | Device: Vdrive Lasso navigationUse of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Left atrial AF ablation procedure requiring the use of a Lasso mapping catheter
- Subject must be at least 18 years of age
- Subject must be male, female of no childbearing potential, or a female that has a negative pregnancy test prior to randomization
Key exclusion criteria (12 listed)
- Unable to safely expose subject to a magnetic field
- Prior AF ablation procedure
- Patients with fewer than 4 PVs are excluded
- Patients with persistent AF in whom early recurrence of AF following cardioversion would preclude completion of the pacing maneuvers described in the protocol or patients with other conditions that would similarly preclude completion of the pacing maneuvers
- Contraindication to procedure or unable to return for follow-up
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 |
|---|---|---|
| Vdrive Lasso navigationRemote robotic Lasso navigation | Device | Vdrive Lasso navigation |
| Manual Lasso navigationManually maneuver a Lasso catheter | Procedure or surgery | Manual Lasso navigation |
Primary outcome
The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.
Time frame: Peri-procedural
Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05.
Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.
Time frame: 7 days Follow-up
The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Atrial Fibrillation (AF)
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.
Qun Sha, MD study director
Stereotaxis Inc
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vdrive Lasso navigation and Manual Lasso navigation in people with Atrial Fibrillation, run by Stereotaxis at 5 sites in 3 countries.
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 3 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: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups. (time frame: Peri-procedural). 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 Jul 2015.