Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

Completed

Conditions studied: Heart Failure

In brief

Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.

Key facts

Study ID

NCT00869921

Run by

Medtronic

People needed

1322

Starts

2009-03-01

Expected to finish

2018-04-03

Last updated by the study team

2018-09-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Patient has or is intended to receive an Attain StarFix Model 4195 LV lead
• Patient within 30 day post implant enrollment window

You may not qualify if…

• Patient who is, or is expected to be inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Chula Vista, California, United States
• Study site — Redding, California, United States
• Study site — Salinas, California, United States
• Study site — Stanford, California, United States
• Study site — Torrance, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Albany, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Newburgh, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Edgewood, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Covington, Louisiana, United States
• Study site — Salisbury, Maryland, United States
• Study site — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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