Tachycardia, VentricularMAGNETIC-VTNCT02637947
Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
A study testing catheter ablation using magnetic navigation and catheter ablation using manual navigation in people with Tachycardia, Ventricular, run by Stereotaxis at 16 sites in 7 countries.
Trial summary
The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular
- What is being tested?
- catheter ablation using magnetic navigation and catheter ablation using manual navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 16 sitesin 7 countries
- Study dates
- Jan 2016to 15 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject has had an ICD previously implanted
- subject has drug-refractory monomorphic VT
- subject is a candidate for ischemic VT RF ablation
- subject has had a myocardial infarction
- subject has a LVEF less than or equal to 35%
Who cannot join
- subject has non-ischemic VT
- subject has a history of stroke within 1 month prior to enrollment
- subject has had an acute myocardial infarction within 30 days prior to enrollment
- subject has unstable angina
- subject has undergone cardiac surgery within 60 days prior to enrollment
- subject is pregnant or nursing
Show all 13Show fewer
- subject has a limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.)
- subject is unable or unwilling to cooperate with study procedures
- subject has a known presence of intracardiac thrombi as determined by echocardiography
- subject has a major contraindication to anticoagulation therapy or coagulation disorder
- subject has had a previous pericarditis or cardiac tumor
- subject has had previous thoracic radiation therapy
- any other reason the investigator considers the subject ineligible
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
United States8 sites
Augusta University
Augusta, Georgia, 30912
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
University of Chicago Medical Center
Chicago, Illinois, 60637
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Intermountain Heart Institute
Murray, Utah, 84107
Weill Cornell Medical
New York, New York, 10065
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Florida Hospital
Orlando, Florida, 32803
Netherlands2 sites
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam
Erasmus Medical Center
Rotterdam
About this study
Official title: A Prospective, Multi-center, Post Market Randomized Controlled Trial Comparing VT Ablation Outcomes Using Remote MAGNETIC Navigation Guided Substrate Mapping and Ablation Versus Manual Approach in a Low LVEF Population
The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.
Read the detailed description
This study is a randomized, single-blind, prospective, multi-center post market evaluation. Subjects will be screened for study eligibility and asked to complete written informed consent prior to any study specific testing assessments. After completing written informed consent, a total of 386 subjects will be randomized on a 1:1 basis to receive VT ablation treatment using either the Niobe ES or standard manual catheter ablation treatment using commercially available products. This will be the largest randomized VT study comparing outcomes from RMN to manually guided catheter ablation procedures. Subjects will be randomized according to a computer-generated randomization scheme. Randomization will be blocked at the study site level and subjects will be blinded to group assignment. Since quality of life measurements will be collected during follow-up, this study is single-blinded in order to mitigate patient bias. Clinical evaluations will not be masked to the treating physician.
- Conditions
- Tachycardia, Ventricular
- Being tested
- catheter ablation using magnetic navigation, catheter ablation using manual navigation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablation using magnetic navigationDevice
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters.
catheter ablation using manual navigationDevice
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic navigation | Experimental | Catheter ablation using magnetic navigation for ventricular tachycardia via remote magnetic navigation of a NaviStar RMT ThermoCool catheter, or other magnetically compatible catheter, via Stereotaxis's Niobe ES system. Receives: Device: catheter ablation using magnetic navigation |
| Manual navigation | Active comparator | Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter. Receives: Device: catheter ablation using manual navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from any VT in the overall cohort
Measured: 12 months
Secondary outcomes (4)
acute success of procedure
non-inducibility of clinical VT and/or other monomorphic VT using typical stimulation protocol for induction
Measured: at end of procedure (immediate)
freedom from VT in large scar subpopulation
Measured: 12 months
major adverse events
death, cardiac tamponade, stroke, bleeding requiring surgical intervention, progressive heart failure related to VT/VF recurrence
Measured: 48 hours post-procedure
mortality rate
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 posted22 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Why it stopped: In the post-market environment, the RCT design did not allow achievement of enrollment goals
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 Tachycardia, VentricularStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637947
- Sponsor's protocol ID
- CLIN-021
- Acronym
- MAGNETIC-VT
- Status last verified
- Sep 2022
- First submitted
- 4 Dec 2015
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Di Biase L, Tung R, Szili-Torok T, Burkhardt JD, Weiss P, Tavernier R, Berman AE, Wissner E, Spear W, Chen X, Neuzil P, Skoda J, Lakkireddy D, Schwagten B, Lock K, Natale A; MAGNETIC VT investigators. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population. J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.
PubMed 28064433
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Post Market Randomized Controlled Trial Comparing VT Ablation Outcomes Using Remote MAGNETIC Navigation Guided Substrate Mapping and Ablation Versus Manual Approach in a Low LVEF Population
- ClinicalTrials.gov ID
- NCT02637947
- Acronym / sponsor ID
- MAGNETIC-VT / CLIN-021
- Conditions
- Tachycardia, Ventricular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In the post-market environment, the RCT design did not allow achievement of enrollment goals
- Enrolment
- 182 participants (actual)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 22 Dec 2015 (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 study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.
Detailed description
This study is a randomized, single-blind, prospective, multi-center post market evaluation. Subjects will be screened for study eligibility and asked to complete written informed consent prior to any study specific testing assessments. After completing written informed consent, a total of 386 subjects will be randomized on a 1:1 basis to receive VT ablation treatment using either the Niobe ES or standard manual catheter ablation treatment using commercially available products. This will be the largest randomized VT study comparing outcomes from RMN to manually guided catheter ablation procedures. Subjects will be randomized according to a computer-generated randomization scheme. Randomization will be blocked at the study site level and subjects will be blinded to group assignment. Since quality of life measurements will be collected during follow-up, this study is single-blinded in order to mitigate patient bias. Clinical evaluations will not be masked to the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic navigation | Experimental | Device: catheter ablation using magnetic navigationCatheter ablation using magnetic navigation for ventricular tachycardia via remote magnetic navigation of a NaviStar RMT ThermoCool catheter, or other magnetically compatible catheter, via Stereotaxis's Niobe ES system. |
| Manual navigation | Active comparator | Device: catheter ablation using manual navigationCatheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- subject has had an ICD previously implanted
- subject has drug-refractory monomorphic VT
- subject is a candidate for ischemic VT RF ablation
- subject has had a myocardial infarction
- subject has a LVEF less than or equal to 35%
Key exclusion criteria (13 listed)
- subject has non-ischemic VT
- subject has a history of stroke within 1 month prior to enrollment
- subject has had an acute myocardial infarction within 30 days prior to enrollment
- subject has unstable angina
- subject has undergone cardiac surgery within 60 days prior to enrollment
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 |
|---|---|---|
| catheter ablation using magnetic navigationelimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters. | Device | Magnetic navigation |
| catheter ablation using manual navigationelimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters. | Device | Manual navigation |
Primary outcome
freedom from any VT in the overall cohort
Time frame: 12 months
4 secondary outcomes
acute success of procedure
Time frame: at end of procedure (immediate)
freedom from VT in large scar subpopulation
Time frame: 12 months
major adverse events
Time frame: 48 hours post-procedure
mortality rate
Time frame: 12 months
Results and safety
The study was stopped early (reason given: In the post-market environment, the RCT design did not allow achievement of enrollment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 28064433Di Biase L, Tung R, Szili-Torok T, Burkhardt JD, Weiss P, Tavernier R, Berman AE, Wissner E, Spear W, Chen X, Neuzil P, Skoda J, Lakkireddy D, Schwagten B, Lock K, Natale A; MAGNETIC VT investigators. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population. J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.
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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.
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter ablation using magnetic navigation and catheter ablation using manual navigation in people with Tachycardia, Ventricular, run by Stereotaxis at 16 sites in 7 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Belgium, Netherlands, Australia, Czechia and 2 more countries. 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 was stopped early (reason given: In the post-market environment, the RCT design did not allow achievement of enrollment goals). Results are not available in the source record.
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?
freedom from any VT in the overall cohort (time frame: 12 months). 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 NCT02637947, 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 27 Sep 2022.