TachycardiaPhase 4NCT00158912
VAST - Ventricular Arrhythmia Suppression Trial
A Phase 4 study testing Implantable Cardioverter Defibrillator in people with Tachycardia, run by Boston Scientific Corporation.
Trial summary
The purpose of VAST is to determine whether the Rate Smoothing feature in Guidant's PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia
- What is being tested?
- Implantable Cardioverter Defibrillator
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to May 2005
- Phase
- Phase 4
- 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
- Adult, Older adult
Who may be able to join
- Patients who receive a commercially available Guidant PRIZM, PRIZM 2, or VITALITY AVT ICD
- Patients who sign and date a Patient Informed Consent prior to study enrollment
- Patients who remain in the clinical care of physicians of their implanting center
Who cannot join
- Patients who have chronic atrial fibrillation. Paroxysms of AF are not an exclusion criterion, but the patient must be in normal sinus rhythm at the time of randomization. If history of AF is unknown or uncertain, or the patient was recently cardioverted, there must be at least 23 hours of normal sinus rhythm within the 24 hour period preceding randomization
- Patients who previously had an ICD
- Patients with current indications for cardiac resynchronization therapy with defibrillation (CRT-D)
- Patients whose life expectancy is less than 12 months due to other medical conditions
- Patients who are expected to receive a heart transplant during the duration of the study
- Patients who have or who are likely to receive a tricuspid or other valve prosthesis
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- Patients who are currently enrolled in another investigational study of active medical therapy. Each instance should be brought to Guidant's Clinical Application Research Studies (CARS) group to determine eligibility
- Patients who are younger than 18 years of age
- Patients who are mentally incompetent and cannot give a Patient Informed Consent or participate in the study
About this study
Official title: Ventricular Arrhythmia Suppression Trial
The purpose of VAST is to determine whether the Rate Smoothing feature in Guidant's PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias.
- Conditions
- Tachycardia
- Being tested
- Implantable Cardioverter Defibrillator
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter DefibrillatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for this study will be the number of episodes of ventricular tachyarrhythmia in each patient during each follow-up period (ON vs. OFF treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 550 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Friedman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158912
- Sponsor's protocol ID
- CR-CA-060903-T
- Status last verified
- Nov 2006
- First submitted
- 7 Sep 2005
- Last updated
- 22 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Arrhythmia Suppression Trial
- ClinicalTrials.gov ID
- NCT00158912
- Acronym / sponsor ID
- CR-CA-060903-T
- Conditions
- Tachycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- May 2005
- First posted
- 12 Sep 2005 (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 purpose of VAST is to determine whether the Rate Smoothing feature in Guidant's PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who receive a commercially available Guidant PRIZM, PRIZM 2, or VITALITY AVT ICD
- Patients who sign and date a Patient Informed Consent prior to study enrollment
- Patients who remain in the clinical care of physicians of their implanting center
Key exclusion criteria (9 listed)
- Patients who have chronic atrial fibrillation. Paroxysms of AF are not an exclusion criterion, but the patient must be in normal sinus rhythm at the time of randomization. If history of AF is unknown or uncertain, or the patient was recently cardioverted, there must be at least 23 hours of normal sinus rhythm within the 24 hour period preceding randomization
- Patients who previously had an ICD
- Patients with current indications for cardiac resynchronization therapy with defibrillation (CRT-D)
- Patients whose life expectancy is less than 12 months due to other medical conditions
- Patients who are expected to receive a heart transplant during the duration of the study
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 |
|---|---|---|
| Implantable Cardioverter Defibrillator | Device | – |
Primary outcome
The primary endpoint for this study will be the number of episodes of ventricular tachyarrhythmia in each patient during each follow-up period (ON vs. OFF treatment).
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 22 Nov 2006.
Related trials for Tachycardia
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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)
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AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
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Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
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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.
Paul Friedman, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantable Cardioverter Defibrillator in people with Tachycardia, run by Boston Scientific Corporation.
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 9 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 22 Nov 2006. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
The primary endpoint for this study will be the number of episodes of ventricular tachyarrhythmia in each patient during each follow-up period (ON vs. OFF treatment).. 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 22 Nov 2006.