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INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement

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ClinicalTrials.gov Identifier: NCT00180440
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 26, 2009
Sponsor:
Information provided by:
Guidant Corporation

Brief 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.

Condition or disease Intervention/treatment
Ventricular Fibrillation Device: ICD

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 Type : Observational
Estimated Enrollment : 528 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: INcidence Free SUrvival Before and After ICD Replacement
Study Start Date : July 2002
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008



Intervention Details:
  • Device: ICD
    all models of Guidant/Bsc ICD's
    Other Name: implantable defibrillator



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients who are considered for ICD replacement due to normal battery depletion
Criteria

Inclusion Criteria:

  • All elective ICD replacements due to battery depletion of the first ICD being implanted in the patient

Exclusion Criteria:

  • Non-availability to regular follow-up
  • Age < 18 years
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180440


Locations
Germany
IKKF, Insitut für Klinisch-kardiovaskuläre Forschung
München, Germany, 80 335
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Johannes Sperzel, MD Kerckhoff Klinik

Responsible Party: Andrea Ungefehr, Guidant Germany a Boston Scientific company
ClinicalTrials.gov Identifier: NCT00180440     History of Changes
Other Study ID Numbers: INSURE 1.3
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes