Heart Failure, Tachycardia, Ventricular
Conditions
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
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
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prior to implant and for whom an implant is unsuccessful will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician and patient choose to do so.
Interventions
DEVICESt. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads. | 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. |
Countries
Belgium, Canada, Germany, Japan, Poland, Portugal, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects Patients implanted with St. Jude Medical Optisure Lead
St. Jude Medical Optisure Lead: Patients implanted with St. Jude Medical Optisure Lead | 1,735 |
| Total | 1,735 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 11.5 |
| Arrhythmia History, n(%) Atrial Arrhythmias | 575 Participants |
| Arrhythmia History, n(%) Ventricular Arrhythmias | 564 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 106 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1568 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 61 Participants |
| NYHA Class per Blinded Assessor at Baseline, n(%) Class I | 179 Participants |
| NYHA Class per Blinded Assessor at Baseline, n(%) Class II | 712 Participants |
| NYHA Class per Blinded Assessor at Baseline, n(%) Class III | 771 Participants |
| NYHA Class per Blinded Assessor at Baseline, n(%) Class IV | 15 Participants |
| NYHA Class per Blinded Assessor at Baseline, n(%) Not Available | 58 Participants |
| Primary CRT-D Indication for Implant, n(%) Cardiac Arrest | 91 Participants |
| Primary CRT-D Indication for Implant, n(%) CRT Generator Change | 8 Participants |
| Primary CRT-D Indication for Implant, n(%) CRT - Other | 9 Participants |
| Primary CRT-D Indication for Implant, n(%) Familial Condition | 19 Participants |
| Primary CRT-D Indication for Implant, n(%) Heart Failure with Atrial Fibrillation | 59 Participants |
| Primary CRT-D Indication for Implant, n(%) Heart Failure with Wide QRS | 379 Participants |
| Primary CRT-D Indication for Implant, n(%) ICD Generator Change | 13 Participants |
| Primary CRT-D Indication for Implant, n(%) ICD - Other | 38 Participants |
| Primary CRT-D Indication for Implant, n(%) Ischemic Cardiomyopathy | 551 Participants |
| Primary CRT-D Indication for Implant, n(%) Non-Ischemic Cardiomyopathy | 330 Participants |
| Primary CRT-D Indication for Implant, n(%) Reduced ejection fraction with Frequent Dependence on V-Pacing | 49 Participants |
| Primary CRT-D Indication for Implant, n(%) Syncope | 29 Participants |
| Primary CRT-D Indication for Implant, n(%) Ventricular Tachycardia | 160 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 9 Participants |
| Race/Ethnicity, Customized Asian | 53 Participants |
| Race/Ethnicity, Customized Black or African American | 188 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized Other | 14 Participants |
| Race/Ethnicity, Customized Unknown | 59 Participants |
| Race/Ethnicity, Customized White | 1409 Participants |
| Sex: Female, Male Female | 399 Participants |
| Sex: Female, Male Male | 1336 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 323 / 1,735 | 323 / 1,735 |
| other Total, other adverse events | 58 / 1,735 | 137 / 1,735 |
| serious Total, serious adverse events | 58 / 1,735 | 134 / 1,735 |
Outcome results
Primary
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.
Time frame: 5 years
Population: Subjects with an attempted implant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| St. Jude Medical Optisure Lead | Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads. | 96.3 % pts free from RV related complications |