Ventricular FibrillationNCT00180440
INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement
An observational study of Ventricular Fibrillation, run by Guidant Corporation at 1 site in Germany.
Trial summary
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Fibrillation
- What is being tested?
- ICD
- Type of treatment
- Medical device
- How many people
- 528 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2002to Nov 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients who are considered for ICD replacement due to normal battery depletion
Who may be able to join
- All elective ICD replacements due to battery depletion of the first ICD being implanted in the patient
Who cannot join
- Non-availability to regular follow-up
- Age < 18 years
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
IKKF, Insitut für Klinisch-kardiovaskuläre Forschung
München, 80 335
About this study
Official title: INcidence Free SUrvival Before and After ICD Replacement
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement.
Read the detailed description
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before \& after their first elective ICD replacement. For this purpose all consecutive ICD patients will be included in the study, whose first implanted device is replaced due to ICD battery depletion (i.e. arrival at battery indicator ERI). ICD replacements due to other reasons can be included if duration of first ICD implantation was > 3 years. All patients included in the trial are regularly followed up until delivery of their first adequate ICD therapy. The collected data shall provide statistically valid information about the risk to patients who never have experienced adequate ICD therapy before the ICD replacement investigated in this study. In the future, these statistical risk data can give additional information to implanting physicians, such as whether an ICD replacement can eventually be omitted in those patients who are at very low risk for the occurrence of ICD therapies. All actually available GUIDANT ICDs with CE certificate can be implanted in this trial.
- Conditions
- Ventricular Fibrillation
- Being tested
- ICD
- Medical subject headings
- Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDDevice
Also called implantable defibrillator
all models of Guidant/Bsc ICD's
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular FibrillationStudies 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
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johannes Sperzel, MD, Principal investigator, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180440
- Sponsor's protocol ID
- INSURE 1.3
- Status last verified
- Mar 2009
- First submitted
- 12 Sep 2005
- Last updated
- 26 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INcidence Free SUrvival Before and After ICD Replacement
- ClinicalTrials.gov ID
- NCT00180440
- Acronym / sponsor ID
- INSURE 1.3
- Conditions
- Ventricular Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 16 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 INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement.
Detailed description
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before \& after their first elective ICD replacement. For this purpose all consecutive ICD patients will be included in the study, whose first implanted device is replaced due to ICD battery depletion (i.e. arrival at battery indicator ERI). ICD replacements due to other reasons can be included if duration of first ICD implantation was > 3 years. All patients included in the trial are regularly followed up until delivery of their first adequate ICD therapy. The collected data shall provide statistically valid information about the risk to patients who never have experienced adequate ICD therapy before the ICD replacement investigated in this study. In the future, these statistical risk data can give additional information to implanting physicians, such as whether an ICD replacement can eventually be omitted in those patients who are at very low risk for the occurrence of ICD therapies. All actually available GUIDANT ICDs with CE certificate can be implanted in this trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients who are considered for ICD replacement due to normal battery depletion
Key inclusion criteria (1 listed)
- All elective ICD replacements due to battery depletion of the first ICD being implanted in the patient
Key exclusion criteria (3 listed)
- Non-availability to regular follow-up
- Age < 18 years
- Pregnancy
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 |
|---|---|---|
| ICDAlso: implantable defibrillatorall models of Guidant/Bsc ICD's | 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 26 Mar 2009.
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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.
Johannes Sperzel, MD principal investigator
Kerckhoff Klinik
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 Fibrillation, run by Guidant Corporation at 1 site in Germany.
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 1 inclusion and 3 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 26 Mar 2009. 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 Germany. 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 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 26 Mar 2009.