Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar

Completed

Conditions studied: Congestive Heart Failure

In brief

The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.

Key facts

Study ID

NCT00810264

Run by

Biotronik, Inc.

People needed

2499

Starts

2008-12-01

Expected to finish

2018-11-02

Last updated by the study team

2019-11-29

Who can join

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

You may qualify if…

• Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead, from 7-180 days prior to enrollment
• Able to understand the nature of the registry and give informed consent
• Available for follow-up visits on a regular basis at the investigational site
• Age greater than or equal to 18 years

You may not qualify if…

• Enrolled in any IDE clinical study
• Planned cardiac surgical procedures or interventional measures within the next 6 months
• Expected to receive a heart transplant within 1 year
• Life expectancy less than 1 year
• Presence of another life-threatening, underlying illness separate from their cardiac disorder
• Pregnancy
• Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Fairfield, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Glendale, California, United States
• Study site — Hawthorne, California, United States
• Study site — Inglewood, California, United States
• Study site — Los Angeles, California, United States
• Study site — National City, California, United States
• Study site — Northridge, California, United States
• Study site — Orange, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Torrance, California, United States
• Study site — Ventura, California, United States
• Study site — Watsonville, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Boulder, Colorado, United States
• Study site — Danbury, Connecticut, United States
• Study site — Brooksville, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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