Status:
COMPLETED
Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
Lead Sponsor:
Biotronik, Inc.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Brief 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 docum...
Detailed Description
This study is an FDA-required, multi-center, prospective, non-randomized, data collection registry. Eligible patients must have been successfully implanted with a Corox OTW BP, Corox OTW-S BP, or Coro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 2 2018
Estimated Enrollment :
2499 Patients enrolled
Trial Details
Trial ID
NCT00810264
Start Date
December 1 2008
End Date
November 2 2018
Last Update
November 29 2019
Active Locations (86)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States
2
Glendale, Arizona, United States
3
Mesa, Arizona, United States
4
Phoenix, Arizona, United States