Status:
TERMINATED
Optisure Lead Post Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Tachycardia, Ventricular
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
Detailed Description
The Optisure lead study is a multi-center, post-approval study that will be performed in compliance with the Conditions for Approval, as agreed upon with the FDA. Patients will be permitted to enroll ...
Eligibility Criteria
Inclusion
- Eligible patients will meet all of the following:
- Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
- Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
- Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion
- Patients will be excluded if they meet any of the following:
- Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study.
- Have a life expectancy of less than 5 years due to any condition.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
1735 Patients enrolled
Trial Details
Trial ID
NCT02235545
Start Date
August 1 2014
End Date
June 30 2020
Last Update
July 30 2025
Active Locations (60)
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1
Baptist Medical Center Princeton
Birmingham, Alabama, United States, 35211
2
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States, 85018
3
St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
Jonesboro, Arkansas, United States, 72401
4
Raymond Schaerf, MD
Burbank, California, United States, 91505