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NCT02235545 · ClinicalTrials.gov registry record
Optisure Lead Post Approval Study
A clinical trial, sponsored by Abbott Medical Devices.
- Terminated
- Registry status
- 1,735
- Enrollment target
NCT02235545: Clinical Trial study, sponsored by Abbott Medical Devices.
NCT02235545 is a clinical trial that was terminated before completion, run by Abbott Medical Devices. The registered enrollment target is 1,735 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02235545 was terminated before completion, sponsored by Abbott Medical Devices.
- TERMINATED
- Registry status
- 1,735 participants
- Enrollment target
Study Summary
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
Primary Outcome
Freedom from right ventricle (RV) lead related complications within 30 days of implant at 5 years follow-up Due to early termination of study, the sample size at 5 years follow-up was insufficient to perform the pre-specified primary endpoint analysis. The endpoint was evaluated using the Kaplan-Meier method however the hypothesis test was not performed due to insufficient sample size. The percentage freedom from RV lead related complications was summarized through 5-years from attempted RV lea
Interventions
- DEVICE St. Jude Medical Optisure Lead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,735 participants |
| Start Date | 2014-08 |
| Est. Completion | 2020-06-30 |
Why NCT02235545 stopped before completion
NCT02235545 is an observational study that tracks outcomes without assigning an intervention. Its 1,735 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which St. Jude Medical Optisure Lead is the first listed.
NCT02235545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02235545 about?
NCT02235545 is a clinical study titled "Optisure Lead Post Approval Study". The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
What is the current status of trial NCT02235545?
This trial is currently terminated. The enrollment target is 1,735 participants. The study started on 2014-08. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT02235545?
The interventions under investigation include: St. Jude Medical Optisure Lead (DEVICE).
Who is sponsoring clinical trial NCT02235545?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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