Trial Outcomes & Findings for Longitudinal Surveillance Registry (LSR) of ACUITY Spiral (NCT NCT00955708)
NCT ID: NCT00955708
Last Updated: 2019-05-02
Results Overview
Recruitment status
TERMINATED
Target enrollment
1308 participants
Primary outcome timeframe
Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
Results posted on
2019-05-02
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
1308
|
|
Overall Study
COMPLETED
|
250
|
|
Overall Study
NOT COMPLETED
|
1058
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Death
|
269
|
|
Overall Study
Lost to Follow-up
|
72
|
|
Overall Study
Physician Decision
|
36
|
|
Overall Study
Protocol Violation
|
134
|
|
Overall Study
Registry Conclusion
|
186
|
|
Overall Study
Product removed from service
|
94
|
|
Overall Study
Patient Refused to participate further
|
116
|
|
Overall Study
Closure of study location
|
60
|
|
Overall Study
Patient changed care provider/moved
|
91
|
Baseline Characteristics
QRS Duration value unavailable for 49 subjects
Baseline characteristics by cohort
| Measure |
Implants
n=1303 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1303 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
387 Participants
n=1303 Participants
|
|
Age, Categorical
>=65 years
|
916 Participants
n=1303 Participants
|
|
Sex: Female, Male
Female
|
357 Participants
n=1303 Participants
|
|
Sex: Female, Male
Male
|
946 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
6 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
5 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
124 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
White
|
1065 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Bosnian
|
1 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
East Indian
|
1 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Filipino
|
1 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Russian
|
1 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
29 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
52 Participants
n=1303 Participants
|
|
Race/Ethnicity, Customized
Vietnamese
|
1 Participants
n=1303 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=1303 Participants
|
|
Region of Enrollment
United States
|
1301 participants
n=1303 Participants
|
|
QRS Duration
|
150 Milliseconds
STANDARD_DEVIATION 31 • n=1254 Participants • QRS Duration value unavailable for 49 subjects
|
|
PR Interval
|
183 milliseconds
STANDARD_DEVIATION 55 • n=958 Participants • PR Interval (ms) unavailable for 354 subjects
|
|
Left Ventricular Ejection Fraction
|
26.8 percentage
STANDARD_DEVIATION 7.9 • n=1278 Participants • Left Ventricular Ejection Fraction unavailable for 25 subjects
|
|
Arrhythmia Conduction Disorder
Left Bundle Branch Block
|
691 Participants
n=1285 Participants • Arrhythmia Conduction Disorder was unavailable for 23 subjects
|
|
Arrhythmia Conduction Disorder
Right Bundle Branch Block
|
149 Participants
n=1285 Participants • Arrhythmia Conduction Disorder was unavailable for 23 subjects
|
|
Arrhythmia Conduction Disorder
Nonspecific Intraventricular Delay
|
228 Participants
n=1285 Participants • Arrhythmia Conduction Disorder was unavailable for 23 subjects
|
|
Arrhythmia Conduction Disorder
No Arrhythmia Conduction Disorder
|
140 Participants
n=1285 Participants • Arrhythmia Conduction Disorder was unavailable for 23 subjects
|
|
Arrhythmia Conduction Disorder
Unknown
|
77 Participants
n=1285 Participants • Arrhythmia Conduction Disorder was unavailable for 23 subjects
|
PRIMARY outcome
Timeframe: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).Outcome measures
| Measure |
Implants
n=1303 Participants
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
|
|---|---|
|
Chronic Left Ventricular Lead-related Complication Free Rate
|
95.3 Percent free from event
Interval 94.0 to
Interval is only calculated for the lower end. The method is defined as the lower one-sided 95% confidence interval compared to the confidence boundary of 92.5%.
|
Adverse Events
Implants
Serious events: 117 serious events
Other events: 131 other events
Deaths: 269 deaths
Serious adverse events
| Measure |
Implants
n=1303 participants at risk
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
|
|---|---|
|
Cardiac disorders
Extracardiac Stimulation, Left Ventricular
|
0.77%
10/1303 • Number of events 10 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Lead Dislodgment, Left Ventricular
|
2.2%
29/1303 • Number of events 29 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Threshold Related, Left Ventricular
|
1.5%
19/1303 • Number of events 19 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.15%
2/1303 • Number of events 2 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Surgical and medical procedures
Cardiac Vessel Dissection
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Surgical and medical procedures
Lead Revision for no heart failure improvement, Left Ventricular
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Accelerated Ventricular Rhythm
|
0.15%
2/1303 • Number of events 2 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Atrial Arrhythmia
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Product Issues
Pulse Generator Possible Malfunction
|
0.15%
2/1303 • Number of events 2 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Surgical and medical procedures
Pulse Generator Related
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Surgical and medical procedures
Erosion/Migration
|
0.69%
9/1303 • Number of events 10 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Heart Failure Decompensation
|
0.15%
2/1303 • Number of events 2 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.15%
2/1303 • Number of events 2 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Surgical and medical procedures
Inability to provide therapy, pulse generator
|
0.38%
5/1303 • Number of events 5 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Surgical and medical procedures
Infection, Procedure related
|
0.77%
10/1303 • Number of events 10 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Premature Ventricular Contractions (PVCs)
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Impedance Related, Atrial Lead
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Injury, poisoning and procedural complications
Infection, Atrial Lead
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Lead Dislodgment, Atrial Lead
|
0.46%
6/1303 • Number of events 6 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Sensing Related, Atrial Lead
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Threshold Related, Atrial Lead
|
0.15%
2/1303 • Number of events 2 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Surgical and medical procedures
Cardiac Perforation, Right Ventricular
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Impedance Related, Right Ventricular
|
0.23%
3/1303 • Number of events 3 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Inappropriate Tachy Therapy, Right Ventricular
|
0.23%
3/1303 • Number of events 3 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Injury, poisoning and procedural complications
Infection, Right Ventricular
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Surgical and medical procedures
Lead Dislodgment, Right Ventricular
|
0.38%
5/1303 • Number of events 5 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Injury, poisoning and procedural complications
Pneumothorax, Right Ventricular
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Sensing Related, Right Ventricular
|
0.08%
1/1303 • Number of events 1 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Threshold Related, Right Ventricular
|
0.38%
5/1303 • Number of events 5 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
Other adverse events
| Measure |
Implants
n=1303 participants at risk
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
|
|---|---|
|
Cardiac disorders
Extracardiac Stimulation, Left Ventricular
|
5.9%
77/1303 • Number of events 88 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Threshold Related, Left Ventricular
|
2.0%
26/1303 • Number of events 33 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
|
Cardiac disorders
Inappropriate Tachy Therapy, Pulse Generator
|
2.1%
28/1303 • Number of events 36 • Adverse Events were collected from the time of enrollment into the trial through completion of the registry at 5 years, date of withdrawal or death.
Adverse event reporting for the LSR of ACUITY Spiral trial included all pulse generator, or lead (Left Ventricular, Right Ventricular or atrial leads are all included) related events occurring at or after implant. Reportable events are defined as inappropriate performance of the pulse generator or leads that result in an undesirable or unanticipated procedure or clinical occurrence.
|
Additional Information
Director of Clinical Trial Management - cRM franchise
Boston Scientific
Phone: 1-800-227-3422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place