NCT00848835

Brief Summary

To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2002

Longer than P75 for all trials

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

March 1, 2002

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 31, 2010

Status Verified

August 1, 2010

Enrollment Period

7.6 years

First QC Date

February 19, 2009

Last Update Submit

August 30, 2010

Conditions

Sudden Cardiac Death

Keywords

defibrillator

Study Arms (1)

control

all patients in the control group

Device: defibrillation lead (ENDOTAK EZ and RELIANCE)

Interventions

defibrillation lead (ENDOTAK EZ and RELIANCE)DEVICE

defibrillation lead

control

Eligibility Criteria

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

all patients who are indicated for a market released ICD

You may qualify if:

  • Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals

You may not qualify if:

  • Patients enrolled in other studies, not available for follow-up, \< 18 yrs, unable to sign consent, life expectancy \< 1 year due to a medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lawrence Sterns, MD

    Victoria Cardiac Arrythmia trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

March 1, 2002

Primary Completion

October 1, 2009

Study Completion

January 1, 2010

Last Updated

August 31, 2010

Record last verified: 2010-08