NCT00180440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

Enrollment Period

6.3 years

First QC Date

September 12, 2005

Last Update Submit

March 25, 2009

Conditions

Ventricular Fibrillation

Interventions

ICDDEVICE

all models of Guidant/Bsc ICD's

Also known as: implantable defibrillator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients who are considered for ICD replacement due to normal battery depletion

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IKKF, Insitut für Klinisch-kardiovaskuläre Forschung

München, 80 335, Germany

Location

MeSH Terms

Conditions

Ventricular Fibrillation

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Johannes Sperzel, MD

    Kerckhoff Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

July 1, 2002

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

DE(1)