Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

Completed

Conditions studied: Heart Failure

In brief

The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring 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 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Key facts

Study ID

NCT00930904

Run by

Medtronic

People needed

1847

Starts

2009-06-01

Expected to finish

2017-04-01

Last updated by the study team

2017-12-27

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 Ability Model 4196 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 — Anchorage, Alaska, United States
• Study site — Gilbert, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — Downey, California, United States
• Study site — East Palo Alto, California, United States
• Study site — Long Beach, California, United States
• Study site — Salinas, California, United States
• Study site — San Bernardino, California, United States
• Study site — Torrance, California, United States
• Study site — Van Nuys, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, 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 — Wellington, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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