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INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement
This study is currently recruiting participants.
Verified by Guidant Corporation, February 2006
Sponsored by: Guidant Corporation
Information provided by: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00180440
  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 IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title: INcidence Free SUrvival Before and After ICD Replacement

Further study details as provided by Guidant Corporation:

Estimated Enrollment: 528
Study Start Date: July 2002
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
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

Contacts
Contact: Andreas Suciu, PhD +49 (0170) 333 9522 asuciu@guidant.com

Locations
Germany
IKKF, Insitut für Klinisch-kardiovaskuläre Forschung Recruiting
München, Germany, 80 335
Contact: Frau Petra Kremer     +49 (089) 54 88 44 250     kremer@ikkf.de    
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Johannes Sperzel, MD Kerckhoff-Klinik
  More Information

Study ID Numbers: INSURE 1.3
Study First Received: September 12, 2005
Last Updated: February 7, 2006
ClinicalTrials.gov Identifier: NCT00180440  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Heart Diseases
Paroxysmal ventricular fibrillation
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009