Ventricular TachycardiaNCT01401608
Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study
An observational study of Ventricular Tachycardia, run by Stereotaxis at 1 site in United States.
Trial summary
This study will assess the outcomes of using magnetic navigation to treat ventricular tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons and are not related to structural heart disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- RF Ablation
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2013
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be diagnosed with any ventricular tachycardia or symptomatic PVCs of non-ischemic origin.
Who may be able to join
- Patients must be between 18 - 80 years of age
- Willing to provide written informed consent
- Present with ventricular ectopy of non-ischemic origin
- able to be safely exposed to a static magnetic field
- Failure of at least 1 antiarrhythmic medication
Who cannot join
- Presence of a mobile ventricular thrombus
- Unable to obtain percutaneous access to the left ventricle
- Contraindicated for short-term anticoagulation therapy
- Life expectancy less than 1 year
- Body habitus limits placement on the procedure table
- Previously failed ablation procedure for VT/PVCs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RF Ablation of Idiopathic VT and PVCs Using Remote Magnetic Navigation
This study will assess the outcomes of using magnetic navigation to treat ventricular tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons and are not related to structural heart disease.
Read the detailed description
During conventional ventricular arrhythmia ablation procedures, simply contacting the cardiac wall can significantly alter the electrocardiogram. Induction of ventricular ectopy is important in determining the focus of the arrhythmogenic tissue during an electrophysiology (EP) procedure; however, instrumentation with stiff ablation catheters can temporarily eliminate VT during the mapping portion of the procedure making it difficult to track the arrhythmia prior to ablating the tissue responsible for its genesis. The catheters used with the Stereotaxis Magnetic Navigation System (MNS) are less stiff compared to manual catheters since no pull wires are required to deflect the distal tip. Large external magnets positioned on either side of the EP procedure table create a magnetic field within the patient's chest. These large magnets (in direct relationship to the magnetic field) can be manipulated using specialized software. The physician controls the distal tip of the catheter by using the software while remotely using a catheter advancing system (QuickCAS®, Stereotaxis, Inc, St. Louis, MO) to reach the desired location within the heart. The soft catheters may provide a unique quality to the electrophysiologist who may assist by providing accurate maps without temporarily eliminating the ventricular ectopy due to excessive mechanical forces applied to the cardiac tissue. This study will assess the physician's ability to appropriately map and ablate the ventricular substrate using remote magnetic technology. All devices are approved by FDA and no off-label use of the products is mandated within the protocol.
- Conditions
- Ventricular Tachycardia
- Being tested
- RF Ablation
- Keywords
- VT, ventricular tachycardia, ablation, magnetic navigation, robotic
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF AblationDevice
Also called ThermoCool, Niobe, Stereotaxis
Ablation of arrhythmogenic ventricular tissue
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Ablation of VT/PVCs using a magnetic RF ablation catheter Receives: Device: RF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour Holter Monitor (number of extra ventricular beats)
Use of the MNS in mapping and ablation of idiopathic VT will lead to a 75% reduction in the number of individual ventricular ectopic beats 6 months after the procedure. Extra ventricular beats will be counted using a 24-hour Holter monitor pre-procedure (obtained no more than 30 days prior to the procedure) compared to a 24-hour Holter monitor 6 months post-procedure.
Measured: Change from Holter Monitor Pre-procedure vs. 6-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 posted25 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Difficult to recruit eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul Weiss, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401608
- Sponsor's protocol ID
- PM-CLIN-015
- Status last verified
- May 2015
- First submitted
- 20 Jul 2011
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RF Ablation of Idiopathic VT and PVCs Using Remote Magnetic Navigation
- ClinicalTrials.gov ID
- NCT01401608
- Acronym / sponsor ID
- PM-CLIN-015
- Conditions
- Ventricular Tachycardia
- Keywords
- VT, ventricular tachycardia, ablation, magnetic navigation, robotic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficult to recruit eligible subjects
- Enrolment
- 6 participants (actual)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jul 2011 (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.
This study will assess the outcomes of using magnetic navigation to treat ventricular tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons and are not related to structural heart disease.
Detailed description
During conventional ventricular arrhythmia ablation procedures, simply contacting the cardiac wall can significantly alter the electrocardiogram. Induction of ventricular ectopy is important in determining the focus of the arrhythmogenic tissue during an electrophysiology (EP) procedure; however, instrumentation with stiff ablation catheters can temporarily eliminate VT during the mapping portion of the procedure making it difficult to track the arrhythmia prior to ablating the tissue responsible for its genesis. The catheters used with the Stereotaxis Magnetic Navigation System (MNS) are less stiff compared to manual catheters since no pull wires are required to deflect the distal tip. Large external magnets positioned on either side of the EP procedure table create a magnetic field within the patient's chest. These large magnets (in direct relationship to the magnetic field) can be manipulated using specialized software. The physician controls the distal tip of the catheter by using the software while remotely using a catheter advancing system (QuickCAS®, Stereotaxis, Inc, St. Louis, MO) to reach the desired location within the heart. The soft catheters may provide a unique quality to the electrophysiologist who may assist by providing accurate maps without temporarily eliminating the ventricular ectopy due to excessive mechanical forces applied to the cardiac tissue. This study will assess the physician's ability to appropriately map and ablate the ventricular substrate using remote magnetic technology. All devices are approved by FDA and no off-label use of the products is mandated within the protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: RF AblationAblation of VT/PVCs using a magnetic RF ablation catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be diagnosed with any ventricular tachycardia or symptomatic PVCs of non-ischemic origin.
Key inclusion criteria (5 listed)
- Patients must be between 18 - 80 years of age
- Willing to provide written informed consent
- Present with ventricular ectopy of non-ischemic origin
- able to be safely exposed to a static magnetic field
- Failure of at least 1 antiarrhythmic medication
Key exclusion criteria (6 listed)
- Presence of a mobile ventricular thrombus
- Unable to obtain percutaneous access to the left ventricle
- Contraindicated for short-term anticoagulation therapy
- Life expectancy less than 1 year
- Body habitus limits placement on the procedure table
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 |
|---|---|---|
| RF AblationAlso: ThermoCool, Niobe, StereotaxisAblation of arrhythmogenic ventricular tissue | Device | Treatment |
Primary outcome
Change in 24-hour Holter Monitor (number of extra ventricular beats)
Time frame: Change from Holter Monitor Pre-procedure vs. 6-Months Post-procedure
Use of the MNS in mapping and ablation of idiopathic VT will lead to a 75% reduction in the number of individual ventricular ectopic beats 6 months after the procedure. Extra ventricular beats will be counted using a 24-hour Holter monitor pre-procedure (obtained no more than 30 days prior to the procedure) compared to a 24-hour Holter monitor 6 months post-procedure.
Results and safety
The study was stopped early (reason given: Difficult to recruit eligible subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
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.
Raul Weiss, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia, run by Stereotaxis at 1 site in United States.
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 6 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 20 May 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 United States. 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: Difficult to recruit eligible subjects). 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?
Change in 24-hour Holter Monitor (number of extra ventricular beats) (time frame: Change from Holter Monitor Pre-procedure vs. 6-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 20 May 2015.