Lead Registry for Optim Leads

Completed

Conditions studied: Optim Lead Insulation Related Adverse Events

In brief

This is a prospective, multi-center, actively monitored, long term data collection registry. Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a compatible market released cardia rhythm management (CRM) implantable pulse generator is eligible for enrollment into the registry.

Key facts

Study ID

NCT01722188

Run by

Abbott Medical Devices

People needed

14124

Starts

2006-08-01

Expected to finish

2020-07-01

Last updated by the study team

2021-05-11

Who can join

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

You may qualify if…

• Patient has a standard indication for a CRM implantable pulse generator.
• Patient receives a market released SJM Optim lead at implant.
• Patient receives a market released CRM implantable pulse generator at implant.
• Patient is willing to provide authorization for registry participation.
• Complete device implant information, including any Optim lead related adverse event is available

You may not qualify if…

• Patient has medical conditions or related factors that would prevent or limit participation (including mechanical tricuspid valves, tricuspid valvular disease, and candidacy for heart transplants within 6 months).
• Patient is < 18 years of age.
• Patient has a life expectancy of < 2 years (malignancies)

Where it is running

• Appalachian Cardiovascular Associates — Fort Payne, Alabama, United States
• North Alabama Cardiology Center — Gadsden, Alabama, United States
• Cardiology Associates of Mobile, Inc. — Mobile, Alabama, United States
• Alaska Heart Institute — Anchorage, Alaska, United States
• Pima Heart Physicians, PC — Tucson, Arizona, United States
• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• Arkansas Cardiology — Little Rock, Arkansas, United States
• *Little Rock Cardiology Clinic — Little Rock, Arkansas, United States
• Northwest Cardiology — Springdale, Arkansas, United States
• Westside Cardiovascular Associates — Beverly Hills, California, United States
• Raymond Schaerf, MD — Burbank, California, United States
• Mills-Peninsula Cardiovascular Specialists — Burlingame, California, United States
• Center for Interventional Cardiology and Nephrology — Encino, California, United States
• Cardiac Institute — Fresno, California, United States
• Mid Valley Cardiology — Fresno, California, United States
• Cardiac Care Specialists — Glendale, California, United States
• Glendale Memorial Hospital and Medical Center — Glendale, California, United States
• Apex Cardiology — Inglewood, California, United States
• Kartik Thaker, MD Inc. — Lakewood, California, United States
• Omid Vahdat M.D. — Los Alamitos, California, United States
• Donna Gallik MD — Los Angeles, California, United States
• Jeffrey Goodman MD — Los Angeles, California, United States
• Payam Yashar M.D. — Los Angeles, California, United States
• Stephen S. Ehrlich, MD — Mission Viejo, California, United States
• Heart South Cardiovascular Group PC — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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