Lead Extract Study (EXTRACT)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
St. Paul Heart Clinic
ClinicalTrials.gov Identifier:
NCT01169441
First received: May 28, 2009
Last updated: July 23, 2010
Last verified: May 2009
  Purpose

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.


Condition
Cardiac Surgical Procedures

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: EXTRACT Study (Data Collection on the Extraction of 2nd and 3rd Generation Defibrillation Leads)

Further study details as provided by St. Paul Heart Clinic:

Enrollment: 100
Study Start Date: November 2006
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects who are scheduled for an ICD lead extraction

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169441

Locations
United States, Minnesota
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
Sponsors and Collaborators
St. Paul Heart Clinic
Medtronic
Investigators
Principal Investigator: Pierce J. Vatterott, M.D. St. Paul Heart Clinic
  More Information

No publications provided

Responsible Party: Pierce Vatterott, MD, St. Paul Heart Clinic
ClinicalTrials.gov Identifier: NCT01169441     History of Changes
Other Study ID Numbers: #2265-4
Study First Received: May 28, 2009
Last Updated: July 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by St. Paul Heart Clinic:
ICD leads
Removal
Extraction
Ventricular leads
Extract
laser
Observe the lead with x-ray during movement and collect information on current ways of removing an ICD lead.

ClinicalTrials.gov processed this record on October 21, 2014