Attain StarFix® 4195 Lead Extraction Study

January 29, 2016 updated by: Medtronic Cardiac Rhythm and Heart Failure

Attain StarFix® Model 4195 LV Lead Extraction Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Sainte-Foy, Quebec, Canada
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Burbank, California, United States
      • Long Beach, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Florida
      • Miami, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • St. Paul, Minnesota, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Removal success of LV leads implanted for more than 180 days
Time Frame: More than 180 days post-implant
More than 180 days post-implant

Secondary Outcome Measures

Outcome Measure
Time Frame
Success of lead removal by how long the lead has been implanted
Time Frame: More than 180 days post-implant
More than 180 days post-implant
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
0 to 45 days post-lead extraction
Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days
Time Frame: 90 -180 days post-implant
90 -180 days post-implant
Summary of tools & techniques used to remove LV leads.
Time Frame: More than 180 days post-implant
More than 180 days post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: 4195 Extraction Study Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StarFix Extraction

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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