Lead Extract Study

Completed

Conditions studied: Cardiac Surgical Procedures

In brief

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 for primary prevention of sudden cardiac death. Due to the younger population, the likelihood of the lead failing during the lifetime of the patient is higher and also more likely to need extraction. To reduce the risk of the lead extraction procedure and therefore reduce the number of abandon leads, ICD lead manufacturers are designing leads to offer improved chronic extractability to reduce the morbidity and mortality during these procedures.

Key facts

Study ID

NCT01169441

Run by

St. Paul Heart Clinic

People needed

100

Starts

2006-11-01

Expected to finish

2010-05-01

Last updated by the study team

2010-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Paul Heart Clinic — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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