Optisure Lead Post Approval Study

Abbott

Status: Terminated

Conditions: Heart Failure; Tachycardia, Ventricular

Treatments: Device: St. Jude Medical Optisure Lead

Study type: Observational

Funder types: Industry

Identifiers

NCT02235545

60045220

Details and patient eligibility

About

The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.

Full 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prior to implant and for whom an implant is unsuccessful will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician and patient choose to do so.

Enrollment: 1,735 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Eligible patients will meet all of the following:

1. 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).
2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
3. 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.
4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion criteria

Patients will be excluded if they meet any of the following:

1. 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.
2. Have a life expectancy of less than 5 years due to any condition.

Trial design

1,735 participants in 1 patient group

St. Jude Medical Optisure Lead

Description:

Patients implanted with St. Jude Medical Optisure Lead

Treatment:

Device: St. Jude Medical Optisure Lead