Status:

COMPLETED

Lead Extract Study

Lead Sponsor:

St. Paul Heart Clinic

Collaborating Sponsors:

Medtronic

Conditions:

Cardiac Surgical Procedures

Eligibility:

All Genders

18+ years

Brief Summary

The recent expansion of indications for implantable cardioverter defibrillators (ICDs) has changed the population of patients being implanted. Younger and healthier patients are now being implanted fo...

Detailed Description

This study will enroll up to 100 subjects at our site only. Prior to the procedure information will be collected including the subjects demographics, medications, medical, cardiovascular and surgical ...

Eligibility Criteria

Inclusion

  • Subjects must be 18 years of age or older,
  • be scheduled for an ICD lead extraction and
  • willing and able to sign the informed consent.

Exclusion

  • Patients with lead implant duration less than 6 months,
  • patients with gross chronic lead infections,
  • patients with epicardial or subcutaneous ICD systems (without transvenous ICD lead) and
  • patients who are pregnant or suspect they may be pregnant.

Key Trial Info

Start Date :

November 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2010

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT01169441

Start Date

November 1 2006

End Date

May 1 2010

Last Update

July 26 2010

Active Locations (1)

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St. Paul Heart Clinic

Saint Paul, Minnesota, United States, 55102