Optisure Lead Post Approval Study

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

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Tachycardia, Ventricular
• Intervention / Treatment: Device: St. Jude Medical Optisure Lead

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prior to implant and for whom an implant is unsuccessful will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician and patient choose to do so.

• Study Type: Observational
• Enrollment (Actual): 1735

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • QE II Health Sciences
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Scarborough, Ontario, Canada, M1B 4Z8
      • Rouge Valley Centenary
  • Quebec
    • Montreal, Quebec, Canada, H1T1C8
      • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
• Germany
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
• Japan
  • Kanto
    • Shinjuku-Ku, Kanto, Japan, 162-8666
      • Tokyo Women's Medical University
  • Osaka
    • Abeno-ku, Osaka, Japan, 545-8565
      • Osaka City University Hospital
  • Tochigi-ken
    • Shimotsuke-shi, Tochigi-ken, Japan, 329-0498
      • Jichi Medical University Hospital
• Poland
  • Lodz, Poland
    • Mc-Tronik
• Portugal
  • Lisbon
    • Lisboa, Lisbon, Portugal, 1649-035
      • Santa Maria Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Baptist Medical Center Princeton
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Phoenix Cardiovascular Research Group
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
  • California
    • Burbank, California, United States, 91505
      • Raymond Schaerf, MD
    • Palm Springs, California, United States, 92262
      • Desert Heart Rhythm Consultants
    • Reseda, California, United States, 91335
      • Cardiac Rhythm Specialists, Inc.
    • San Diego, California, United States, 92103
      • San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Jorge Diaz, M.D. , P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Rockford Cardiology Associates
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Medical Center - South Unit
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Peninsula Cardiology Associates
  • Massachusetts
    • Leominster, Massachusetts, United States, 01453
      • Mass Heart & Rhythm
  • Michigan
    • Flint, Michigan, United States, 48532
      • Premier Medical Clinics
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
    • Traverse City, Michigan, United States, 49684
      • Northern Michigan Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates of North Mississippi
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • HealthCare Partners Cardiology
  • New Jersey
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of the Delaware Valley
    • Voorhees, New Jersey, United States, 08043
      • Lourdes Cardiology Services
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Presbyterian Heart Group
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • Brooklyn, New York, United States, 11235
      • Coney Island Hospital
    • Liverpool, New York, United States, 13088
      • Cardiovascular Group of Syracuse
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • High Point Regional Health (formerly Carolina Cardiology Cornerstone)
    • New Bern, North Carolina, United States, 28562
      • CarolinaEast Heart Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • VA Medical Center Cleveland
    • Willoughby, Ohio, United States, 44094
      • Great Lakes Medical Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart and Vascular Institute
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18105
      • Lehigh Valley Hospital
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Newtown, Pennsylvania, United States, 18940
      • Arrhythmia Institute
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation
  • Texas
    • Bedford, Texas, United States, 76021
      • HeartPlace
    • Dallas, Texas, United States, 75216
      • VA Medical Center Dallas
    • El Paso, Texas, United States, 79936
      • Cardiology Care Consultants
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Utah
    • Saint George, Utah, United States, 84790
      • Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)
  • Virginia
    • Fredericksburg, Virginia, United States, 22401
      • Mary Washington Hospital
    • Richmond, Virginia, United States, 23229
      • Virginia Cardiovascular Specialists
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ICD/CRT-D indicated patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
St. Jude Medical Optisure Lead; Patients implanted with St. Jude Medical Optisure Lead	Device: St. Jude Medical Optisure Lead; Patients implanted with St. Jude Medical Optisure Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads.	Freedom from right ventricle (RV) lead related complications within 30 days of implant at 5 years follow-up Due to early termination of study, the sample size at 5 years follow-up was insufficient to perform the pre-specified primary endpoint analysis. The endpoint was evaluated using the Kaplan-Meier method however the hypothesis test was not performed due to insufficient sample size. The percentage freedom from RV lead related complications was summarized through 5-years from attempted RV lead implant. For subjects who experienced RV lead related complication, the time to event will be calculated from the attempted implant to the date that the first event occurred. For subjects that did not experience the complication, the time to event was censored at their last known event-free time point.	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Optisure Lead-Related Complication Rates	Date at which all patients have completed their five year follow-up.

Other Outcome Measures

Outcome Measure	Time Frame
Optisure Lead Related Adverse Events	Date at which all patients have completed their five year follow-up.
The annual hazard rate of lead electrical dysfunction	Date at which all patients have completed their five year follow-up.
The annual hazard rate of externalized conductors	Date at which all patients have completed their five year follow-up.
The annual hazard rate of other visual lead anomalies by each subcategory	Date at which all patients have completed their five year follow-up.
Prevalence of "other insulation anomalies" in "returned leads	Date at which all patients have completed their five year follow-up.
Time from externalized conductors to electrical dysfunction	Date at which all patients have completed their five year follow-up.
Time from other visual lead anomalies by each subcategory to electrical dysfunction	Date at which all patients have completed their five year follow-up.
Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other)	Date at which all patients have completed their five year follow-up.
Time from externalized conductors to clinical intervention	Date at which all patients have completed their five year follow-up.
Time from other visual lead anomalies by each subcategory to clinical intervention	Date at which all patients have completed their five year follow-up.
Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies) to those without lead compromise	Date at which all patients have completed their five year follow-up.
Comparison of patients with electrical dysfunction to those without electrical dysfunction.	Date at which all patients have completed their five year follow-up.

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Nicole Harbert, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: September 7, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimated): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Implantable Cardioverter Defibrillator (ICD); Treatment of Heart Failure; Treamtent of life-threatening ventricular tachyarrhythmia; Optisure; High Voltage (HV) Lead; cardiac resynchronization therapy defibrillator (CRT-D) System
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Failure; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 60045220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes