Lead Extract Study

NCT ID: NCT01169441

Last Updated: 2010-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-05-31

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 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.

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 history. During the lead extraction procedure specific data will be gathered which includes items such as: total lead length, lead length from insertion site to connector end of lead just prior to lead extraction, extraction tools used and the physician description of the extraction. The patients will undergo an assessment of extraction force up to 3 kilograms maximum to the ICD lead for a specified amount of time before the use of laser or extraction sheaths. Extraction forces and approximate times will be monitored and recorded throughout the procedure. Forces will be measured by using a force gauge. Xrays will be taken to show lead position during movement of the arm at the side, above the head and across the chest. Fluoroscopy images of the heart may be saved. The amount of extra time added to the case in order to perform this study and collect the data is estimated at 10 minutes. Participation in the study is complete following the procedure. There is a 30-day follow-up phone call to capture any adverse events which require a clinic visit, ER visit or hospitalization.

Conditions

Cardiac Surgical Procedures

Study Design

• Observational Model Type: COHORT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

St. Paul Heart Clinic

OTHER

Sponsor Role: lead

Responsible Party

St. Paul Heart Clinic

Principal Investigators

Pierce J. Vatterott, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Paul Heart Clinic

Locations

St. Paul Heart Clinic

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

#2265-4

Identifier Type: -

Identifier Source: org_study_id