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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180440
First Posted: September 16, 2005
Last Update Posted: March 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guidant Corporation
  Purpose
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 Intervention Phase
Ventricular Fibrillation Device: ICD Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: INcidence Free SUrvival Before and After ICD Replacement

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Estimated Enrollment: 528
Study Start Date: July 2002
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ICD
    all models of Guidant/Bsc ICD's
    Other Name: implantable defibrillator
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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 Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: March 26, 2009
Last Verified: March 2009

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