Lead Extract Study

Cardiac Surgical Procedures Clinical Trial

— EXTRACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169441
• Other study ID #: #2265-4
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: July 23, 2010
• Start date: November 2006
• Est. completion date: May 2010

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Locations

Country	Name	City	State
United States	St. Paul Heart Clinic	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
St. Paul Heart Clinic	Medtronic

Country where clinical trial is conducted

United States,