Cardiomyopathy, Heart Failure
Conditions
Keywords
Heart Failure, Cardiomyopathy, Cardiac pacing, Cardiac resynchronization therapy
Brief summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart. The purpose of this study is to monitor the long-term performance of the InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy (CRT).
Detailed description
Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.
Interventions
DEVICEInSync Model 8040
Subjects with sucessful implants of InSync Model 8040.
DEVICEInSync III Model 8042
Subjects with successful implants of InSync III Model 8042
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients implanted with an InSync Model 8040 or InSync III Model 8042, a right ventricular lead, and a Medtronic market-released left ventricular lead as part of a system to deliver cardiac resynchronization therapy.
Exclusion criteria
* Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync Registry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. | 36 month follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular (LV) Lead R-wave Amplitude | 36 month follow-up | Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up. |
| Left Ventricular (LV) Lead Impedance | 36 months follow-up | Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up. |
| Left Ventricular (LV) Lead Pacing Voltage Threshold | 36 months follow-up | Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up |
| Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant | 36 months follow-up | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects 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. | 1,999 |
| Total | 1,999 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 450 |
| Overall Study | Device/System Explant | 154 |
| Overall Study | Lost to Follow-up | 88 |
| Overall Study | Site exit, system change, 36 m FU missed | 36 |
| Overall Study | Withdrawal by Subject | 257 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1313 Participants |
| Age, Categorical Between 18 and 65 years | 686 Participants |
| Age Continuous | 67.2 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment United States | 1999 participants |
| Sex: Female, Male Female | 728 Participants |
| Sex: Female, Male Male | 1271 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 175 / 1,999 |
| serious Total, serious adverse events | 450 / 1,999 |
Outcome results
Primary
Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.
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
Time frame: 36 month follow-up
Population: The analysis included data from all subjects enrolled in the InSync Registry study and successfully implanted with the InSync or InSync III system.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects | Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. | Overall Death | 450 participants |
| All Subjects | Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. | Cause Specific Death | 213 participants |
Comparison: For overall mortality, the endpoint is the proportion of subjects alive during three years post-implant. Survival curves of overall mortality and cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals will be calculated on a log-log scale.95% CI: [68.6, 73.2]Kaplan-Meier (product limit) estimates
Comparison: For cause-specific mortality, the endpoint is the proportion of patients who are alive or do not die due to the progressive heart failure or sudden cardiac death causes during 3 years post-implant. Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals were calculated on a log-log scale.95% CI: [83.3, 87.1]Kaplan-Meier (product limit) estimates
Secondary
Left Ventricular (LV) Lead Impedance
Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.
Time frame: 36 months follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Subjects | Left Ventricular (LV) Lead Impedance | 6 months follow-up | 620 ohms |
| All Subjects | Left Ventricular (LV) Lead Impedance | 12 months follow-up | 625 ohms |
| All Subjects | Left Ventricular (LV) Lead Impedance | 18 months follow-up | 628 ohms |
| All Subjects | Left Ventricular (LV) Lead Impedance | 24 months follow-up | 622 ohms |
| All Subjects | Left Ventricular (LV) Lead Impedance | 30 months follow-up | 632 ohms |
| All Subjects | Left Ventricular (LV) Lead Impedance | 36 months follow-up | 633 ohms |
Secondary
Left Ventricular (LV) Lead Pacing Voltage Threshold
Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up
Time frame: 36 months follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Subjects | Left Ventricular (LV) Lead Pacing Voltage Threshold | 6 months follow-up | 1.70 Volts |
| All Subjects | Left Ventricular (LV) Lead Pacing Voltage Threshold | 12 months follow-up | 1.65 Volts |
| All Subjects | Left Ventricular (LV) Lead Pacing Voltage Threshold | 18 months follow-up | 1.69 Volts |
| All Subjects | Left Ventricular (LV) Lead Pacing Voltage Threshold | 24 months follow-up | 1.72 Volts |
| All Subjects | Left Ventricular (LV) Lead Pacing Voltage Threshold | 30 months follow-up | 1.76 Volts |
| All Subjects | Left Ventricular (LV) Lead Pacing Voltage Threshold | 36 months follow-up | 1.76 Volts |
Secondary
Left Ventricular (LV) Lead R-wave Amplitude
Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.
Time frame: 36 month follow-up
Population: 1999 subjects successfully implanted with a left ventricular lead as part of a Medtronic CRT/CRT-D system.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Subjects | Left Ventricular (LV) Lead R-wave Amplitude | 6 months follow-up | 13.7 mV |
| All Subjects | Left Ventricular (LV) Lead R-wave Amplitude | 12 months follow-up | 13.3 mV |
| All Subjects | Left Ventricular (LV) Lead R-wave Amplitude | 18 months follow-up | 13.2 mV |
| All Subjects | Left Ventricular (LV) Lead R-wave Amplitude | 24 months follow-up | 13.2 mV |
| All Subjects | Left Ventricular (LV) Lead R-wave Amplitude | 30 months follow-up | 13.4 mV |
| All Subjects | Left Ventricular (LV) Lead R-wave Amplitude | 36 months follow-up | 13.6 mV |
Secondary
Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant
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.
Time frame: 36 months follow-up
Population: The analysis included data from all subjects enrolled in the InSync Registry study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant | 176 participants |
Comparison: Kaplan-Meier (product limit) estimate of the curve representing the time to first post-implant LV lead related complication were calculated to the first time point where fewer than 50 patients are still at risk. Confidence intervals will be calculated on a log-log scale.95% CI: [88.3, 91.2]Kaplan-Meier (product limit) estimate