Cardiac Surgical Procedures Clinical Trial
— EXTRACTOfficial title:
EXTRACT Study (Data Collection on the Extraction of 2nd and 3rd Generation Defibrillation Leads)
Verified date | May 2009 |
Source | St. Paul Heart Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Observational Model: Cohort
Country | Name | City | State |
---|---|---|---|
United States | St. Paul Heart Clinic | St. Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
St. Paul Heart Clinic | Medtronic |
United States,
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