TachyarrhythmiaPhase 4NCT00231426
ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations
A Phase 4 study testing ICD in people with Tachyarrhythmia, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmia
- What is being tested?
- ICD
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Nov 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 meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices
- Patients who sign and date a Patient Informed Consent form prior to the implant visit
- Patients who remain in the clinical care of the enrolling physician in approved centers
- Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex
- Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV
Who cannot join
- Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies
- Patients who undergo lead repositioning
- 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 valve prosthesis
- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
- Patients who are younger than 18 years of age
Show all 9Show fewer
- Patients who are pregnant or plan to become pregnant during the study
- Patients whose life expectancy is less than 12 months
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.
- Conditions
- Tachyarrhythmia
- Being tested
- ICD
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startJun 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies 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
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John D Day, M.D., Principal investigator, LDS Hospital, Salt Lake City, Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231426
- Sponsor's protocol ID
- CR-CA-031203-M
- Status last verified
- Nov 2006
- First submitted
- 30 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
- Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study
- ClinicalTrials.gov ID
- NCT00231426
- Acronym / sponsor ID
- CR-CA-031203-M
- Conditions
- Tachyarrhythmia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Nov 2005
- First posted
- 4 Oct 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 ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices
- Patients who sign and date a Patient Informed Consent form prior to the implant visit
- Patients who remain in the clinical care of the enrolling physician in approved centers
- Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex
- Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV
Key exclusion criteria (9 listed)
- Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies
- Patients who undergo lead repositioning
- 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 valve prosthesis
- Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current 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 |
|---|---|---|
| ICD | Device | – |
Primary outcome
Not reported in the source record.
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.
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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.
John D Day, M.D. principal investigator
LDS Hospital, Salt Lake City, Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ICD in people with Tachyarrhythmia, run by Boston Scientific Corporation 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 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.
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.
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.
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.