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

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180440
First received: September 12, 2005
Last updated: March 25, 2009
Last verified: March 2009
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Andrea Ungefehr, Guidant Germany a Boston Scientific company
ClinicalTrials.gov Identifier: NCT00180440     History of Changes
Other Study ID Numbers: INSURE 1.3
Study First Received: September 12, 2005
Last Updated: March 25, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 15, 2014