Attain StarFix® 4195 Lead Extraction Study

Completed

Conditions studied: Heart Failure, Indications for Lead Removal

In brief

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.

Key facts

Study ID

NCT00893386

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

227

Starts

2009-07-01

Expected to finish

2015-04-01

Last updated by the study team

2016-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• None

Where it is running

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

Full record on ClinicalTrials.gov

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