Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
NCT00810264 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2499
Last updated 2019-11-29
Summary
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.
Conditions
- Congestive Heart Failure
Interventions
- DEVICE
-
CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.
Sponsors & Collaborators
-
Biotronik, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-12-31
- Primary Completion
- 2018-11-02
- Completion
- 2018-11-02
Countries
- United States
Study Locations
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