Attain StarFix® 4195 Lead Extraction Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00893386
First received: April 28, 2009
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. This study is required by the Food and Drug Administration (FDA) as a condition of approval for the Attain StarFix® Model 4195 LV Lead.


Condition Intervention
Heart Failure
Indications for Lead Removal
Procedure: LV Lead Extraction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Attain StarFix® Model 4195 LV Lead Extraction Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Removal success of LV leads implanted for more than 180 days [ Time Frame: More than 180 days post-implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success of lead removal by how long the lead has been implanted [ Time Frame: More than 180 days post-implant ] [ Designated as safety issue: No ]
  • Adverse Events that are related to the LV lead, the extraction procedure, or the extraction tool. [ Time Frame: 0 to 45 days post-lead extraction ] [ Designated as safety issue: No ]
  • Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days [ Time Frame: 90 -180 days post-implant ] [ Designated as safety issue: No ]
  • Summary of tools & techniques used to remove LV leads. [ Time Frame: More than 180 days post-implant ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-4195 Lead, 181 days
Patients with a Medtronic LV Lead, other than Model 4195, implanted at least 181 days
Procedure: LV Lead Extraction
Removal of a LV lead using any tools & techniques.
4195 Lead, 181 days
Patients with a Medtronic Model 4195 LV Lead implanted at least 181 days
Procedure: LV Lead Extraction
Removal of a LV lead using any tools & techniques.
4195 Lead, 90-180 days
Patients with Medtronic Model 4195 LV Lead implanted for 90-180 days
Procedure: LV Lead Extraction
Removal of a LV lead using any tools & techniques.

  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

Patients will be chosen by investigators participating in the study at up to 25 experienced extraction centers throughout the United States and Canada. Patients of both genders that are indicated for a Model 4195 or a non-Model 4195 Medtronic lead extraction who meet all inclusion criteria may be in the study.

Criteria

Inclusion Criteria:

  • Subjects with a Class I/II indication and/or physician discretion for left ventricular lead removal
  • Medtronic Model 4195 LV lead implanted for at least 181 days at time of extraction, or other Medtronic LV Lead (non-Model 4195) implanted for at least 181 days at time of extraction, or Medtronic Model 4195 LV lead implanted for 90-180 days
  • Intention to remove the LV lead prior to the extraction procedure
  • Subject is 18 years of age or older
  • Subject (or subject's legally authorized representative) has signed and dated the Patient Consent Form and is willing and able to comply with the protocol

Exclusion Criteria:

  • None
  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: NCT00893386

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Burbank, California, United States
Long Beach, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Florida
Miami, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
St. Paul, Minnesota, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
United States, Washington
Spokane, Washington, United States
Canada, Ontario
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Sainte-Foy, Quebec, Canada
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: 4195 Extraction Study Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00893386     History of Changes
Other Study ID Numbers: StarFix Extraction
Study First Received: April 28, 2009
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Extraction
Removal
Lead
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014