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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).
Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Patients implanted with InSync Model 8040, InSync III Model 8042 , or Medtronic CRT-D system. A total of 1999 subjects were enrolled in the study. Of them, 1738 had successful post market implants of InSync Model 8040 (601 subjects), InSync III Model 8042 (512 subjects) and CRT-D devices (625 subjects). The rest 262 subjects came from two pre-market studies: the MIRACLE study added 141 subjects to InSync Model 8040, and the InSync III study added 121 subjects to the InSync III Model 8042. A total of 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InSync Model 8040 | Device | Subjects with sucessful implants of InSync Model 8040. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 month follow-up |
| Left Ventricular (LV) Lead Impedance |
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Inclusion Criteria:
Exclusion Criteria:
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Patients indicated for use of a cardiac device
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| Name | Affiliation | Role |
|---|---|---|
| InSync Registry Study Leader | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19719485 | Derived | Johnson WB, Abraham WT, Young JB, Wheelan K, Smith AL, Chang Y, Brinkman P; InSync Registry Investigators. Long-term performance of the attain model 4193 left ventricular lead. Pacing Clin Electrophysiol. 2009 Sep;32(9):1111-6. doi: 10.1111/j.1540-8159.2009.02451.x. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| InSync III Model 8042 |
| Device |
Subjects with successful implants of InSync III Model 8042 |
|
Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.
| 36 months follow-up |
| 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 | 36 months follow-up |
| 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. | 36 months follow-up |
| Peoria |
| Arizona |
| United States |
| Fort Smith | Arkansas | United States |
| Little Rock | Arkansas | United States |
| Long Beach | California | United States |
| Napa | California | United States |
| Oxnard | California | United States |
| San Diego | California | United States |
| Yuba City | California | United States |
| Washington D.C. | District of Columbia | United States |
| Gainesville | Florida | United States |
| Jacksonville | Florida | United States |
| Jupiter | Florida | United States |
| Melbourne | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | United States |
| Rockford | Illinois | United States |
| Springfield | Illinois | United States |
| Indianapolis | Indiana | United States |
| Des Moines | Iowa | United States |
| Kansas City | Kansas | United States |
| Overland Park | Kansas | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Lake Charles | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Baltimore | Maryland | United States |
| Salisbury | Maryland | United States |
| Silver Spring | Maryland | United States |
| Boston | Massachusetts | United States |
| Worchester | Massachusetts | United States |
| Detroit | Michigan | United States |
| Kalamazoo | Michigan | United States |
| Lansing | Michigan | United States |
| Marquette | Michigan | United States |
| Saginaw | Michigan | United States |
| Duluth | Minnesota | United States |
| Minneapolis | Minnesota | United States |
| Hattiesburg | Mississippi | United States |
| Tupelo | Mississippi | United States |
| Columbia | Missouri | United States |
| Kansas City | Missouri | United States |
| Saint Joseph | Missouri | United States |
| Springfield | Missouri | United States |
| St Louis | Missouri | United States |
| Billings | Montana | United States |
| Lincoln | Nebraska | United States |
| Newark | New Jersey | United States |
| Manhasset | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| High Pointe | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Mayfield Heights | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Doylestown | Pennsylvania | United States |
| Erie | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| York | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Greenville | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Lubbock | Texas | United States |
| Sherman | Texas | United States |
| Salt Lake City | Utah | United States |
| Richmond | Virginia | United States |
| Virginia Beach | Virginia | United States |
| Seattle | Washington | United States |
| Morgantown | West Virginia | United States |
| Milwaukee | Wisconsin | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | The analysis included data from all subjects enrolled in the InSync Registry study and successfully implanted with the InSync or InSync III system. | Posted | Number | participants | 36 month follow-up |
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| 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. | 1999 subjects successfully implanted with a left ventricular lead as part of a Medtronic CRT/CRT-D system. | Posted | Mean | 95% Confidence Interval | mV | 36 month follow-up |
|
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| 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. | Posted | Mean | 95% Confidence Interval | ohms | 36 months follow-up |
|
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| 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 | Posted | Mean | 95% Confidence Interval | Volts | 36 months follow-up |
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| 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. | The analysis included data from all subjects enrolled in the InSync Registry study. | Posted | Number | participants | 36 months follow-up |
|
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36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | The analysis included data from all subjects enrolled in the InSync Registry study. | 450 | 1,999 | 175 | 1,999 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Death and adverse events which resulted in hospitalization are listed as serious adverse events. There was no AE resulted in hospitalization in this study. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 4194 lv lead explanted | General disorders | Systematic Assessment | Only LV lead related AEs are reported for this study. |
| |
| Elevated pacing thresholds | General disorders | Systematic Assessment |
| ||
| Exit block | General disorders | Systematic Assessment |
| ||
| Failure to capture, loss of capture | General disorders | Systematic Assessment |
| ||
| Heart failure decompensation | General disorders | Systematic Assessment |
| ||
| Hypotension | General disorders | Systematic Assessment |
| ||
| Lead conductor fracture | General disorders | Systematic Assessment |
| ||
| Lead dislodgment | General disorders | Systematic Assessment |
| ||
| Lead insulation failure | General disorders | Systematic Assessment |
| ||
| Muscle stimulation-diaphragm | General disorders | Systematic Assessment |
| ||
| Other (IPG code) | General disorders | Systematic Assessment |
| ||
| Oversensing | General disorders | Systematic Assessment |
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| Pacemaker mediated tachycardia | General disorders | Systematic Assessment |
| ||
| Pocket erosion | General disorders | Systematic Assessment |
| ||
| Suboptimal position of 4194 lead | General disorders | Systematic Assessment |
| ||
| Unable to defibrillate | General disorders | Systematic Assessment |
| ||
| Undersensing | General disorders | Systematic Assessment |
| ||
| Ventricular fibrillation | General disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| InSync Registry Clinical Trial Leader | Medtronic, Inc. | medtroniccrmtrials@medtronic.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| No |
| Superiority or Other |
| 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. | Kaplan-Meier (product limit) estimates | Cause specific survival rate at 36 month. | No p value for this analysis. | Cause specific survival rate at 36 month | 85.3 | 2-Sided | 95 | 83.3 | 87.1 | left-truncation methods were used in the survival analysis for previously implanted subjects. | No | Superiority or Other |
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