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

Ventricular Fibrillation Clinical Trial

Official title:

INcidence Free SUrvival Before and After ICD Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180440
• Other study ID #: INSURE 1.3
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: March 25, 2009
• Start date: July 2002
• Est. completion date: November 2008

Study information

• Verified date: March 2009
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ventricular Fibrillation

Intervention

Device:
• ICD
all models of Guidant/Bsc ICD's

Locations

Country	Name	City	State
Germany	IKKF, Insitut für Klinisch-kardiovaskuläre Forschung	München

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Country where clinical trial is conducted

Germany,