Optisure Lead Post Approval Study

Stopped early

Conditions studied: Heart Failure, Tachycardia, Ventricular

In brief

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

Key facts

Study ID

NCT02235545

Run by

Abbott Medical Devices

People needed

1735

Starts

2014-08-01

Expected to finish

2020-06-30

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
• St. Bernards (formerly Cardiology Associates of Northeast Arkansas) — Jonesboro, Arkansas, United States
• Raymond Schaerf, MD — Burbank, California, United States
• Desert Heart Rhythm Consultants — Palm Springs, California, United States
• Cardiac Rhythm Specialists, Inc. — Reseda, California, United States
• San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates) — San Diego, California, United States
• Jorge Diaz, M.D. , P.A. — Lake Mary, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Rockford Cardiology Associates — Rockford, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• St. Elizabeth Medical Center - South Unit — Edgewood, Kentucky, United States
• Peninsula Cardiology Associates — Salisbury, Maryland, United States
• Mass Heart & Rhythm — Leominster, Massachusetts, United States
• Premier Medical Clinics — Flint, Michigan, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• Northern Michigan Hospital — Traverse City, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• Cardiology Associates of North Mississippi — Tupelo, Mississippi, United States
• HealthCare Partners Cardiology — Las Vegas, Nevada, United States
• Cardiovascular Associates of the Delaware Valley — Haddon Heights, New Jersey, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• Presbyterian Heart Group — Albuquerque, New Mexico, United States
• Baptist Medical Center Princeton — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.