NCT01169441

Lead Extract Study

EXTRACT Study (Data Collection on the Extraction of 2nd and 3rd Generation Defibrillation Leads)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: St. Paul Heart Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2010-07-26
• Last updated: 2010-07-26

Locations

1 site across 1 country: United States