TerminatedNot Applicable

Optisure Lead Post Approval Study

Stopped: Abbott received FDA approval to transition the ongoing Optisure PAS to a Real World Evidence methodology through the EP Passion project

United States1,735 participantsStarted 2014-08

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads.

Timeframe: 5 years

NCT IDNCT02235545

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-12-16

Results submitted2022-01-11