Optisure Lead Post Approval Study

NCT02235545 | Terminated Results FDA Device

• 1 other identifier: 60045220
• Study Type: observational
• Target: 1,735
• Locations: 7 countries
• Sites: 60

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.

Conditions

Heart Failure; Tachycardia, Ventricular

Keywords

High Voltage (HV) Lead; Implantable Cardioverter Defibrillator (ICD); cardiac resynchronization therapy defibrillator (CRT-D) System; Treatment of Heart Failure; Treamtent of life-threatening ventricular tachyarrhythmia; Optisure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

St. Jude Medical Optisure Lead

Patients implanted with St. Jude Medical Optisure Lead

Device: St. Jude Medical Optisure Lead

Interventions

St. Jude Medical Optisure Lead DEVICE

Patients implanted with St. Jude Medical Optisure Lead

St. Jude Medical Optisure Lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICD/CRT-D indicated patients

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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (60)

Baptist Medical Center Princeton

Birmingham, Alabama, 35211, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

St. Bernards (formerly Cardiology Associates of Northeast Arkansas)

Jonesboro, Arkansas, 72401, United States

Location

Raymond Schaerf, MD

Burbank, California, 91505, United States

Location

Desert Heart Rhythm Consultants

Palm Springs, California, 92262, United States

Location

Cardiac Rhythm Specialists, Inc.

Reseda, California, 91335, United States

Location

San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)

San Diego, California, 92103, United States

Location

Jorge Diaz, M.D. , P.A.

Lake Mary, Florida, 32746, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Rockford Cardiology Associates

Rockford, Illinois, 61107, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

St. Elizabeth Medical Center - South Unit

Edgewood, Kentucky, 41017, United States

Location

Peninsula Cardiology Associates

Salisbury, Maryland, 21804, United States

Location

Mass Heart & Rhythm

Leominster, Massachusetts, 01453, United States

Location

Premier Medical Clinics

Flint, Michigan, 48532, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Northern Michigan Hospital

Traverse City, Michigan, 49684, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801, United States

Location

HealthCare Partners Cardiology

Las Vegas, Nevada, 89109, United States

Location

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

Presbyterian Heart Group

Albuquerque, New Mexico, 87106, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Coney Island Hospital

Brooklyn, New York, 11235, United States

Location

Cardiovascular Group of Syracuse

Liverpool, New York, 13088, United States

Location

High Point Regional Health (formerly Carolina Cardiology Cornerstone)

High Point, North Carolina, 27262, United States

Location

CarolinaEast Heart Center

New Bern, North Carolina, 28562, United States

Location

VA Medical Center Cleveland

Cleveland, Ohio, 44106, United States

Location

Great Lakes Medical Research, LLC

Willoughby, Ohio, 44094, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Arrhythmia Institute

Newtown, Pennsylvania, 18940, United States

Location

The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

HeartPlace

Bedford, Texas, 76021, United States

Location

VA Medical Center Dallas

Dallas, Texas, 75216, United States

Location

Cardiology Care Consultants

El Paso, Texas, 79936, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)

St. George, Utah, 84790, United States

Location

Mary Washington Hospital

Fredericksburg, Virginia, 22401, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23229, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

QE II Health Sciences

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Rouge Valley Centenary

Scarborough Village, Ontario, M1B 4Z8, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, H1T1C8, Canada

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Tokyo Women's Medical University

Shinjuku-Ku, Kanto, 162-8666, Japan

Location

Osaka City University Hospital

Abeno-ku, Osaka, 545-8565, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

Mc-Tronik

Lodz, Poland

Location

Santa Maria Hospital

Lisbon, Lisbon District, 1649-035, Portugal

Location

MeSH Terms

Conditions

Heart Failure; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicole Harbert, Program Director
• Organization: Abbott

nicole.harbert@abbott.com

1 972-526-4841

Study Officials

• Nicole Harbert

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2014
• First Posted: September 10, 2014
• Study Start: August 1, 2014
• Primary Completion: December 16, 2019
• Study Completion: June 30, 2020
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Locations

BE (1); DE (1); US (46); CA (7); PL (1); JP (3); PT (1)