Trial Outcomes & Findings for InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry (NCT NCT00273182)
NCT ID: NCT00273182
Last Updated: 2013-08-05
Results Overview
Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules
COMPLETED
1999 participants
36 month follow-up
2013-08-05
Participant Flow
The InSync Registry commenced subject enrollment on February 27, 2002. A total of 1999 subjects were enrolled in the study during the time period of February 2002 through February 2008. 1014 subjects completed the study through 36 month follow up. Follow-up of 1000 subjects was required by the FDA to satisfy the conditions of approval.
1999 subjects were enrolled in the study. Of them 1738 had successful post market implants of InSync Model 8040 (n=601), InSync III Model 8042 (n=512) and CRT-D devices (n=625). The rest 262 subjects came from two pre-market studies: MIRACLE study added 141 subjects to InSync Model 8040, InSync III study added 121 to InSync III Model 8042.
Participant milestones
| Measure |
All Subjects
Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
|
|---|---|
|
Overall Study
STARTED
|
1999
|
|
Overall Study
COMPLETED
|
1014
|
|
Overall Study
NOT COMPLETED
|
985
|
Reasons for withdrawal
| Measure |
All Subjects
Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
|
|---|---|
|
Overall Study
Death
|
450
|
|
Overall Study
Lost to Follow-up
|
88
|
|
Overall Study
Withdrawal by Subject
|
257
|
|
Overall Study
Device/System Explant
|
154
|
|
Overall Study
Site exit, system change, 36 m FU missed
|
36
|
Baseline Characteristics
InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry
Baseline characteristics by cohort
| Measure |
All Subjects
n=1999 Participants
Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
686 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1313 Participants
n=5 Participants
|
|
Age Continuous
|
67.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
728 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1271 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1999 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 month follow-upPopulation: The analysis included data from all subjects enrolled in the InSync Registry study and successfully implanted with the InSync or InSync III system.
Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules
Outcome measures
| Measure |
All Subjects
n=1999 Participants
Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
|
|---|---|
|
Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.
Overall Death
|
450 participants
|
|
Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.
Cause Specific Death
|
213 participants
|
SECONDARY outcome
Timeframe: 36 month follow-upPopulation: 1999 subjects successfully implanted with a left ventricular lead as part of a Medtronic CRT/CRT-D system.
Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.
Outcome measures
| Measure |
All Subjects
n=1999 Participants
Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
|
|---|---|
|
Left Ventricular (LV) Lead R-wave Amplitude
6 months follow-up
|
13.7 mV
Interval 13.4 to 14.1
|
|
Left Ventricular (LV) Lead R-wave Amplitude
12 months follow-up
|
13.3 mV
Interval 13.0 to 13.7
|
|
Left Ventricular (LV) Lead R-wave Amplitude
18 months follow-up
|
13.2 mV
Interval 12.8 to 13.6
|
|
Left Ventricular (LV) Lead R-wave Amplitude
24 months follow-up
|
13.2 mV
Interval 12.8 to 13.6
|
|
Left Ventricular (LV) Lead R-wave Amplitude
30 months follow-up
|
13.4 mV
Interval 13.0 to 13.8
|
|
Left Ventricular (LV) Lead R-wave Amplitude
36 months follow-up
|
13.6 mV
Interval 13.1 to 14.1
|
SECONDARY outcome
Timeframe: 36 months follow-upSummary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.
Outcome measures
| Measure |
All Subjects
n=1999 Participants
Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
|
|---|---|
|
Left Ventricular (LV) Lead Impedance
6 months follow-up
|
620 ohms
Interval 609.0 to 630.0
|
|
Left Ventricular (LV) Lead Impedance
12 months follow-up
|
625 ohms
Interval 613.0 to 636.0
|
|
Left Ventricular (LV) Lead Impedance
18 months follow-up
|
628 ohms
Interval 615.0 to 641.0
|
|
Left Ventricular (LV) Lead Impedance
24 months follow-up
|
622 ohms
Interval 608.0 to 635.0
|
|
Left Ventricular (LV) Lead Impedance
30 months follow-up
|
632 ohms
Interval 617.0 to 646.0
|
|
Left Ventricular (LV) Lead Impedance
36 months follow-up
|
633 ohms
Interval 619.0 to 648.0
|
SECONDARY outcome
Timeframe: 36 months follow-upSummary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up
Outcome measures
| Measure |
All Subjects
n=1999 Participants
Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
|
|---|---|
|
Left Ventricular (LV) Lead Pacing Voltage Threshold
6 months follow-up
|
1.70 Volts
Interval 1.63 to 1.77
|
|
Left Ventricular (LV) Lead Pacing Voltage Threshold
12 months follow-up
|
1.65 Volts
Interval 1.59 to 1.72
|
|
Left Ventricular (LV) Lead Pacing Voltage Threshold
18 months follow-up
|
1.69 Volts
Interval 1.62 to 1.77
|
|
Left Ventricular (LV) Lead Pacing Voltage Threshold
24 months follow-up
|
1.72 Volts
Interval 1.64 to 1.81
|
|
Left Ventricular (LV) Lead Pacing Voltage Threshold
30 months follow-up
|
1.76 Volts
Interval 1.67 to 1.85
|
|
Left Ventricular (LV) Lead Pacing Voltage Threshold
36 months follow-up
|
1.76 Volts
Interval 1.67 to 1.85
|
SECONDARY outcome
Timeframe: 36 months follow-upPopulation: The analysis included data from all subjects enrolled in the InSync Registry study.
A left ventricular lead related complication is defined as an adverse event that requires invasive intervention or leads to loss of significant device function resulting from the presence or performance of the LV lead. Kaplan-Meier method was used to estimate complication-free rate during the three years of follow-up. Time to the first post-implant LV lead related complication was used for the calculation. Confidence intervals were calculated on a log-log scale.
Outcome measures
| Measure |
All Subjects
n=1999 Participants
Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
|
|---|---|
|
Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant
|
176 participants
|
Adverse Events
All Patients
Serious adverse events
| Measure |
All Patients
n=1999 participants at risk
The analysis included data from all subjects enrolled in the InSync Registry study.
|
|---|---|
|
General disorders
Death
|
22.5%
450/1999 • Number of events 450 • 36 months
|
Other adverse events
| Measure |
All Patients
n=1999 participants at risk
The analysis included data from all subjects enrolled in the InSync Registry study.
|
|---|---|
|
General disorders
4194 lv lead explanted
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Elevated pacing thresholds
|
0.90%
18/1999 • Number of events 18 • 36 months
|
|
General disorders
Exit block
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Failure to capture, loss of capture
|
2.0%
40/1999 • Number of events 41 • 36 months
|
|
General disorders
Heart failure decompensation
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Hypotension
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Lead conductor fracture
|
0.10%
2/1999 • Number of events 2 • 36 months
|
|
General disorders
Lead dislodgment
|
3.5%
70/1999 • Number of events 75 • 36 months
|
|
General disorders
Lead insulation failure
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Muscle stimulation-diaphragm
|
2.4%
47/1999 • Number of events 49 • 36 months
|
|
General disorders
Other (IPG code)
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Oversensing
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Pacemaker mediated tachycardia
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Pocket erosion
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Suboptimal position of 4194 lead
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Unable to defibrillate
|
0.05%
1/1999 • Number of events 1 • 36 months
|
|
General disorders
Undersensing
|
0.10%
2/1999 • Number of events 2 • 36 months
|
|
General disorders
Ventricular fibrillation
|
0.05%
1/1999 • Number of events 1 • 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PI's may not publish single-site data until the main multi-site publication has occurred.
- Publication restrictions are in place
Restriction type: OTHER