Heart Failure
Conditions
Brief summary
The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.
Interventions
DEVICEACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Has been or will be implanted with the ACUITY Spiral Lead within 29 days * Plans to remain in the long-term care of his/her enrolling physician * Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB) * Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry
Exclusion criteria
* Is unable or unwilling to comply with the protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic Left Ventricular Lead-related Complication Free Rate | Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implants Patients successfully implanted or underwent an attempted implant with the ACUITY Spiral Lead
ACUITY Spiral Left Ventricular Lead: The implant of the ACUITY Spiral Lead | 1,303 |
| Total | 1,303 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Closure of study location | 60 |
| Overall Study | Death | 269 |
| Overall Study | Lost to Follow-up | 72 |
| Overall Study | Patient changed care provider/moved | 91 |
| Overall Study | Patient Refused to participate further | 116 |
| Overall Study | Physician Decision | 36 |
| Overall Study | Product removed from service | 94 |
| Overall Study | Protocol Violation | 134 |
| Overall Study | Registry Conclusion | 186 |
Baseline characteristics
| Characteristic | Implants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 916 Participants |
| Age, Categorical Between 18 and 65 years | 387 Participants |
| Arrhythmia Conduction Disorder Left Bundle Branch Block | 691 Participants |
| Arrhythmia Conduction Disorder No Arrhythmia Conduction Disorder | 140 Participants |
| Arrhythmia Conduction Disorder Nonspecific Intraventricular Delay | 228 Participants |
| Arrhythmia Conduction Disorder Right Bundle Branch Block | 149 Participants |
| Arrhythmia Conduction Disorder Unknown | 77 Participants |
| Left Ventricular Ejection Fraction | 26.8 percentage STANDARD_DEVIATION 7.9 |
| PR Interval | 183 milliseconds STANDARD_DEVIATION 55 |
| QRS Duration | 150 Milliseconds STANDARD_DEVIATION 31 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 6 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 124 Participants |
| Race/Ethnicity, Customized Bosnian | 1 Participants |
| Race/Ethnicity, Customized East Indian | 1 Participants |
| Race/Ethnicity, Customized Filipino | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 52 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 5 Participants |
| Race/Ethnicity, Customized Russian | 1 Participants |
| Race/Ethnicity, Customized Unknown | 29 Participants |
| Race/Ethnicity, Customized Vietnamese | 1 Participants |
| Race/Ethnicity, Customized White | 1065 Participants |
| Region of Enrollment Puerto Rico | 2 participants |
| Region of Enrollment United States | 1301 participants |
| Sex: Female, Male Female | 357 Participants |
| Sex: Female, Male Male | 946 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 269 / 1,303 |
| other Total, other adverse events | 131 / 1,303 |
| serious Total, serious adverse events | 117 / 1,303 |
Outcome results
Primary
Chronic Left Ventricular Lead-related Complication Free Rate
Time frame: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implants | Chronic Left Ventricular Lead-related Complication Free Rate | 95.3 Percent free from event |
Comparison: The endpoint data reflected here is a modified primary endpoint analysis requested by the Food and Drug Administration early in the registry to include data that is related to the left ventricular lead function in a chronic setting.
Comparison: The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here.