Ventricular TachycardiaPhase 3VeTAMedNCT01798277
Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia
A Phase 3 study testing Catheter Ablation and Medical therapy (sotalol or amiodarone) in people with Ventricular Tachycardia and Coronary Artery Disease, run by Newmarket Electrophysiology Research Group Inc.
Trial summary
This study aims to compare antiarrhythmic drug therapy with catheter ablation using the SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular tachycardia and coronary artery disease Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventricular Tachycardia, Coronary Artery Disease
- What is being tested?
- Catheter Ablation and Medical therapy (sotalol or amiodarone)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sustained monomorphic VT (>30 seconds, or requiring appropriate ICD therapy in patients with ICDs)
- Documented ischemic heart disease with no further options for revascularization
- Ability and willingness to give written informed consent to participate in the trial
Who cannot join
- VT in the setting of metabolic abnormalities or acute ischemia if coronary lesions suitable for revascularization are identified.
- Acute ischemia with eligibility for revascularization
- Significant peripheral arterial disease preventing transvascular access to the left ventricle.
- Patients with arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy, Brugada syndrome, Long QT syndromes, dilated cardiomyopathy
- Prior long term therapy with a Class III or Class IC antiarrhythmic agent (longer than 2 weeks)
- Patient is or may be potentially pregnant
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- Patient has a mechanical heart valve
- Myocardial infarction within the past 90 days
- Stroke within the past 90 days
- New York Heart Association (NYHA) functional class IV
- Hemorrhagic manifestations, bleeding diathesis, or impairment of hemostasis
- Lesions at risk of clinically significant bleeding (e.g., extensive cerebral infarction within the last 6 months, active peptic ulcer disease with recent bleeding)
- Prior VT ablation procedure
- Contraindication or allergy to contrast media, routine procedural medications or catheter materials
- Contraindications to an interventional procedure
- Life expectancy is less than 6 months
- Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
- Untreated hypothyroidism or hyperthyroidism (euthyroid or thyroid hrt is acceptable)
- Current enrolment in another investigational drug or device study
- There are other conditions present that the investigator feels would be problematic or would restrict or limit the participation for the patient for the entire study period
- Absolute contraindication to the use of heparin or warfarin
- Documented intra-arterial thrombus, ventricular thrombus, (less than 6 months after detection of thrombus), tumor or other abnormality that precludes catheter introduction
About this study
Official title: Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)
This study aims to compare antiarrhythmic drug therapy with catheter ablation using the SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular tachycardia and coronary artery disease
Read the detailed description
This is a multicenter, randomized prospective cohort study to compare the impact of catheter ablation with antiarrhythmic drug therapy for treating patients with sustained ventricular tachycardia (VT) and coronary artery disease. Patients that meet all inclusion criteria and no exclusion criteria will be recruited to the study cohort. After baseline measurements are taken, patients will be randomized in a 2:1 fashion to either undergo radiofrequency catheter ablation or receive antiarrhythmic drug therapy (amiodarone or sotalol). The in-clinic appointments include: enrollment, baseline, intervention, and follow-up every three months for one year post-ablation. At each follow-up visit, electrogram (ECG) and Holter monitoring tests will be performed to measure any episodes of ventricular tachyarrhythmia. Furthermore, interrogation of the patient's implantable cardioverter defibrillator (ICD) will be performed at all follow-up visits to detect any episodes of ventricular tachyarrhythmia that required antitachycardia pacing (ATP) or shocks.
- Conditions
- Ventricular Tachycardia, Coronary Artery Disease
- Being tested
- Catheter Ablation, Medical therapy (sotalol or amiodarone)
- Keywords
- Keywords provided by Newmarket Electrophysiology Research Group Inc:, Ventricular tachycardia, Ventricular tachyarrhythmia, Ablation, Coronary artery disease, Ischemic heart disease, Amiodarone, Sotalol, Anti-Arrhythmia Agents, Therapeutic Uses, Pharmacologic Actions, Additional relevant MeSH terms:, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Catheter Ablation, Radiofrequency
- Medical subject headings
- Tachycardia, Ventricular, Coronary Artery Disease, Myocardial Ischemia, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
Also called Ablation of:, - Ischemic ventricular tachycardia, - Sustained monomorphic ventricular tachycardia, - Clinical ventricular tachycardia
Catheter ablation of ventricular tachycardia will employ three-dimensional mapping Fast Anatomical Mapping or CARTOSOUND technology (Biosense Webster Inc.), and the Thermocool Navistar catheter (Biosense Webster Inc.).
Medical therapy (sotalol or amiodarone)Drug
Also called Sotalol - Betapace, Betapace AF, Sotalex, Sotacor
Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation | Active comparator | Radiofrequency ablation procedure Receives: Procedure: Catheter Ablation |
| Medical therapy | Active comparator | Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician. Receives: Drug: Medical therapy (sotalol or amiodarone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Ventricular Tachycardia
Number of any appropriate ATPs/shocks and/or presentations of sustained (>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention
Measured: 1 year
Secondary outcomes (6)
Time to First Shock/ATP for VT or to First Presentation of Sustained VT
Change in time to first ATP/shock or presentation of sustained (>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention
Measured: 1 year
Total mortality
Change in mortality status at 3, 6, 9 and 12 months after intervention
Measured: 1 year
Sudden cardiac death
Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention
Measured: 1 year
Syncope
Change in syncope status at 3, 6, 9 and 12 months after intervention
Measured: 1 year
Number of hospitalizations
Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention
Measured: 1 year
QOL measures
Change in QOL measures at 6 and 12 months after intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Low Enrolment
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newmarket Electrophysiology Research Group Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Yaariv Khaykin, MD, Principal investigator, Newmarket Electrophysiology Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798277
- Sponsor's protocol ID
- NERG-02
- Acronym
- VeTAMed
- Status last verified
- Jan 2015
- First submitted
- 20 Feb 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)
- ClinicalTrials.gov ID
- NCT01798277
- Acronym / sponsor ID
- VeTAMed / NERG-02
- Conditions
- Ventricular Tachycardia, Coronary Artery Disease
- Keywords
- Keywords provided by Newmarket Electrophysiology Research Group Inc:, Ventricular tachycardia, Ventricular tachyarrhythmia, Ablation, Coronary artery disease, Ischemic heart disease, Amiodarone, Sotalol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low Enrolment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Newmarket Electrophysiology Research Group IncUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Feb 2013 (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 aims to compare antiarrhythmic drug therapy with catheter ablation using the SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular tachycardia and coronary artery disease
Detailed description
This is a multicenter, randomized prospective cohort study to compare the impact of catheter ablation with antiarrhythmic drug therapy for treating patients with sustained ventricular tachycardia (VT) and coronary artery disease. Patients that meet all inclusion criteria and no exclusion criteria will be recruited to the study cohort. After baseline measurements are taken, patients will be randomized in a 2:1 fashion to either undergo radiofrequency catheter ablation or receive antiarrhythmic drug therapy (amiodarone or sotalol). The in-clinic appointments include: enrollment, baseline, intervention, and follow-up every three months for one year post-ablation. At each follow-up visit, electrogram (ECG) and Holter monitoring tests will be performed to measure any episodes of ventricular tachyarrhythmia. Furthermore, interrogation of the patient's implantable cardioverter defibrillator (ICD) will be performed at all follow-up visits to detect any episodes of ventricular tachyarrhythmia that required antitachycardia pacing (ATP) or shocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation | Active comparator | Procedure: Catheter AblationRadiofrequency ablation procedure |
| Medical therapy | Active comparator | Drug: Medical therapy (sotalol or amiodarone)Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sustained monomorphic VT (>30 seconds, or requiring appropriate ICD therapy in patients with ICDs)
- Documented ischemic heart disease with no further options for revascularization
- Ability and willingness to give written informed consent to participate in the trial
Key exclusion criteria (22 listed)
- VT in the setting of metabolic abnormalities or acute ischemia if coronary lesions suitable for revascularization are identified.
- Acute ischemia with eligibility for revascularization
- Significant peripheral arterial disease preventing transvascular access to the left ventricle.
- Patients with arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy, Brugada syndrome, Long QT syndromes, dilated cardiomyopathy
- Prior long term therapy with a Class III or Class IC antiarrhythmic agent (longer than 2 weeks)
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 AblationAlso: Ablation of:, - Ischemic ventricular tachycardia, - Sustained monomorphic ventricular tachycardia, - Clinical ventricular tachycardiaCatheter ablation of ventricular tachycardia will employ three-dimensional mapping Fast Anatomical Mapping or CARTOSOUND technology (Biosense Webster Inc.), and the Thermocool Navistar catheter (Biosense Webster Inc.). | Procedure or surgery | Catheter Ablation |
| Medical therapy (sotalol or amiodarone)Also: Sotalol - Betapace, Betapace AF, Sotalex, SotacorPatients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone). | Drug | Medical therapy |
Primary outcome
Recurrence of Ventricular Tachycardia
Time frame: 1 year
Number of any appropriate ATPs/shocks and/or presentations of sustained (>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention
6 secondary outcomes
Time to First Shock/ATP for VT or to First Presentation of Sustained VT
Time frame: 1 year
Total mortality
Time frame: 1 year
Sudden cardiac death
Time frame: 1 year
Syncope
Time frame: 1 year
Number of hospitalizations
Time frame: 1 year
QOL measures
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
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
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.
Yaariv Khaykin, MD principal investigator
Newmarket Electrophysiology Research Group
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Catheter Ablation and Medical therapy (sotalol or amiodarone) in people with Ventricular Tachycardia and Coronary Artery Disease, run by Newmarket Electrophysiology Research Group Inc.
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 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: withdrawn, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Recurrence of Ventricular Tachycardia (time frame: 1 year). 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 27 Jan 2015.