Optisure Lead Post Approval Study
- Conditions
- Heart FailureTachycardia, Ventricular
- Interventions
- Device: St. Jude Medical Optisure Lead
- Registration Number
- NCT02235545
- Lead Sponsor
- Abbott Medical Devices
- Brief 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1735
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description St. Jude Medical Optisure Lead St. Jude Medical Optisure Lead Patients implanted with St. Jude Medical Optisure Lead
- Primary Outcome Measures
Name Time Method Freedom from RV Lead Related Complications Date at which all patients have completed their five year follow-up.
- Secondary Outcome Measures
Name Time Method Optisure Lead-Related Complication Rates Date at which all patients have completed their five year follow-up.
Trial Locations
- Locations (60)
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Cardiology Associates of North Mississippi
🇺🇸Tupelo, Mississippi, United States
VA Medical Center Cleveland
🇺🇸Cleveland, Ohio, United States
VA Medical Center Dallas
🇺🇸Dallas, Texas, United States
Mary Washington Hospital
🇺🇸Fredericksburg, Virginia, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
🇺🇸San Diego, California, United States
HealthCare Partners Cardiology
🇺🇸Las Vegas, Nevada, United States
Jorge Diaz, M.D. , P.A.
🇺🇸Lake Mary, Florida, United States
St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
🇺🇸Jonesboro, Arkansas, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Baptist Medical Center Princeton
🇺🇸Birmingham, Alabama, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Providence Heart and Vascular Institute
🇺🇸Portland, Oregon, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸Reseda, California, United States
Rockford Cardiology Associates
🇺🇸Rockford, Illinois, United States
Lourdes Cardiology Services
🇺🇸Voorhees, New Jersey, United States
Peninsula Cardiology Associates
🇺🇸Salisbury, Maryland, United States
Coney Island Hospital
🇺🇸Brooklyn, New York, United States
St. Elizabeth Medical Center - South Unit
🇺🇸Edgewood, Kentucky, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Northern Michigan Hospital
🇺🇸Traverse City, Michigan, United States
HeartPlace
🇺🇸Bedford, Texas, United States
Tokyo Women's Medical University
🇯🇵Shinjuku-Ku, Kanto, Japan
Desert Heart Rhythm Consultants
🇺🇸Palm Springs, California, United States
Cardiovascular Group of Syracuse
🇺🇸Liverpool, New York, United States
High Point Regional Health (formerly Carolina Cardiology Cornerstone)
🇺🇸High Point, North Carolina, United States
CarolinaEast Heart Center
🇺🇸New Bern, North Carolina, United States
Great Lakes Medical Research, LLC
🇺🇸Willoughby, Ohio, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
The Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
Arrhythmia Institute
🇺🇸Newtown, Pennsylvania, United States
Virginia Cardiovascular Specialists
🇺🇸Richmond, Virginia, United States
Cardiology Care Consultants
🇺🇸El Paso, Texas, United States
QE II Health Sciences
🇨🇦Halifax, Nova Scotia, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montreal, Quebec, Canada
Rouge Valley Centenary
🇨🇦Scarborough, Ontario, Canada
Universitäts-Herzzentrum Freiburg - Bad Krozingen
🇩🇪Bad Krozingen, Germany
Osaka City University Hospital
🇯🇵Abeno-ku, Osaka, Japan
Mc-Tronik
🇵🇱Lodz, Poland
Cardiovascular Associates of the Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
Raymond Schaerf, MD
🇺🇸Burbank, California, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Mass Heart & Rhythm
🇺🇸Leominster, Massachusetts, United States
Ziekenhuis Oost-Limburg
🇧🇪Genk, Limburg, Belgium
Jichi Medical University Hospital
🇯🇵Shimotsuke-shi, Tochigi-ken, Japan
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Premier Medical Clinics
🇺🇸Flint, Michigan, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
Santa Maria Hospital
🇵🇹Lisboa, Lisbon, Portugal
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)
🇺🇸Saint George, Utah, United States
Aurora Medical Group
🇺🇸Milwaukee, Wisconsin, United States
Presbyterian Heart Group
🇺🇸Albuquerque, New Mexico, United States