NCT02235545

Optisure Lead Post Approval Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,735 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 in the study up to 30 days post-implant of the Optisure lead. Following a successful implant, patients will be followed every 6 months until 60 months (5 years). After patients complete 60 months of follow-up, their participation in the study will end. Patients who are consented prior to implant and for whom an implant is unsuccessful will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician and patient choose to do so.

Conditions

• Heart Failure
• Tachycardia, Ventricular

Interventions

Type	Name	Description
DEVICE	St. Jude Medical Optisure Lead	Patients implanted with St. Jude Medical Optisure Lead

Timeline

• Start date: 2014-08-01
• Primary completion: 2019-12-16
• Completion: 2020-06-30
• First posted: 2014-09-10
• Last updated: 2025-07-30
• Results posted: 2025-07-30

Locations

60 sites across 7 countries: United States, Belgium, Canada, Germany, Japan, Poland, Portugal

Regulatory

• FDA-regulated device study