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Completed

NCT Number: NCT00893386

Attain StarFix® 4195 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Indications for Lead Removal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LV Lead Extraction

Procedure

Removal of a LV lead using any tools & techniques.

Primary outcomes

  1. Removal success of LV leads implanted for more than 180 days

    Time frame: More than 180 days post-implant

Secondary outcomes

  1. Success of lead removal by how long the lead has been implanted

    Time frame: More than 180 days post-implant

  2. 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

  3. Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days

    Time frame: 90 -180 days post-implant

  4. Summary of tools & techniques used to remove LV leads.

    Time frame: More than 180 days post-implant

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Attain StarFix® Model 4195 LV Lead Extraction Study

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 6, 2009
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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