Heart FailureNCT02235545
Optisure Lead Post Approval Study
An observational study of Heart Failure and Tachycardia, Ventricular, run by Abbott Medical Devices at 60 sites in 7 countries.
Trial summary
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Tachycardia, Ventricular
- What is being tested?
- St. Jude Medical Optisure Lead
- Type of treatment
- Medical device
- How many people
- 1,735 participants
- Where
- 60 sitesin 7 countries
- Study dates
- Aug 2014to 30 Jun 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICD/CRT-D indicated patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
60 sites in 7 countries.
60 sites in 7 countries
United States46 sites
Presbyterian Heart Group
Albuquerque, New Mexico, 87106
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
Northside Hospital
Atlanta, Georgia, 30342
HeartPlace
Bedford, Texas, 76021
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
Maimonides Medical Center
Brooklyn, New York, 11219
Coney Island Hospital
Brooklyn, New York, 11235
Raymond Schaerf, MD
Burbank, California, 91505
VA Medical Center Cleveland
Cleveland, Ohio, 44106
VA Medical Center Dallas
Dallas, Texas, 75216
St. Elizabeth Medical Center - South Unit
Edgewood, Kentucky, 41017
Cardiology Care Consultants
El Paso, Texas, 79936
Premier Medical Clinics
Flint, Michigan, 48532
Parkview Research Center
Fort Wayne, Indiana, 46845
Mary Washington Hospital
Fredericksburg, Virginia, 22401
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035
High Point Regional Health (formerly Carolina Cardiology Cornerstone)
High Point, North Carolina, 27262
Jackson Heart Clinic
Jackson, Mississippi, 39216
St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
Jonesboro, Arkansas, 72401
Jorge Diaz, M.D. , P.A.
Lake Mary, Florida, 32746
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
HealthCare Partners Cardiology
Las Vegas, Nevada, 89109
Mass Heart & Rhythm
Leominster, Massachusetts, 01453
Cardiovascular Group of Syracuse
Liverpool, New York, 13088
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
CarolinaEast Heart Center
New Bern, North Carolina, 28562
Arrhythmia Institute
Newtown, Pennsylvania, 18940
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Desert Heart Rhythm Consultants
Palm Springs, California, 92262
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018
Providence Heart and Vascular Institute
Portland, Oregon, 97225
Cardiac Rhythm Specialists, Inc.
Reseda, California, 91335
Virginia Cardiovascular Specialists
Richmond, Virginia, 23229
Rockford Cardiology Associates
Rockford, Illinois, 61107
Peninsula Cardiology Associates
Salisbury, Maryland, 21804
San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
San Diego, California, 92103
Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)
St. George, Utah, 84790
Scott & White Memorial Hospital
Temple, Texas, 76508
Northern Michigan Hospital
Traverse City, Michigan, 49684
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
Iowa Heart Center
West Des Moines, Iowa, 50266
Great Lakes Medical Research, LLC
Willoughby, Ohio, 44094
Canada7 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
QE II Health Sciences
Halifax, Nova Scotia, B3H 3A7
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario, N6A 5A5
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T1C8
Rouge Valley Centenary
Scarborough Village, Ontario, M1B 4Z8
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Japan3 sites
Osaka City University Hospital
Abeno-ku, Osaka, 545-8565
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498
Tokyo Women's Medical University
Shinjuku-Ku, Kanto, 162-8666
Germany1 site
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79189
About this study
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
Read the 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.
- Conditions
- Heart Failure, Tachycardia, Ventricular
- Being tested
- St. Jude Medical Optisure Lead
- 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
- Medical subject headings
- Heart Failure, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. Jude Medical Optisure LeadDevice
Patients implanted with St. Jude Medical Optisure Lead
| Study group | Role | What they receive |
|---|---|---|
| St. Jude Medical Optisure Lead | Patients implanted with St. Jude Medical Optisure Lead Receives: Device: St. Jude Medical Optisure Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startAug 2014
- Primary completion16 Dec 2019
- Study completion30 Jun 2020
Why it stopped: Abbott received FDA approval to transition the ongoing Optisure PAS to a Real World Evidence methodology through the EP Passion project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,735 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Harbert, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235545
- Sponsor's protocol ID
- 60045220
- Status last verified
- Jul 2025
- First submitted
- 7 Sep 2014
- Last updated
- 30 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optisure Lead Post Approval Study
- ClinicalTrials.gov ID
- NCT02235545
- Acronym / sponsor ID
- 60045220
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Abbott received FDA approval to transition the ongoing Optisure PAS to a Real World Evidence methodology through the EP Passion project
- Enrolment
- 1,735 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Posted 30 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| St. Jude Medical Optisure Lead | – | Device: St. Jude Medical Optisure LeadPatients implanted with St. Jude Medical Optisure Lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD/CRT-D indicated patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| St. Jude Medical Optisure LeadPatients implanted with St. Jude Medical Optisure Lead | Device | St. Jude Medical Optisure Lead |
Primary outcome
Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads.
Time frame: 5 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Harbert study director
Abbott
60 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Tachycardia, Ventricular, run by Abbott Medical Devices at 60 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, Japan, Belgium, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.