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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 (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4196 Lead | Experimental | Non-randomized study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing Lead | Device | implant and follow-up of study device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Subjects Without a Model 4196 Lead Related Complication) | A subject who was free of a Model 4196 lead related complication by one month visit. | One Month |
| Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) | Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms]) | One Month |
| Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) | Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms]) | Three Months |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Successfully Implanted With Model 4196 Lead | A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately. | Implant |
| Subjects Successfully Implanted After Cannulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Ramza, MD, PHD | St. Luke's Mid America Heart Institute, Kansas City MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage | Alaska | United States | ||||
Total number of patients enrolled after meeting inclusion/exclusion criteria was 190. Total number of patients that received an implant attempt was 186. Total number of patients with a 4196 lead attempt was 177. Total number of patients successfully implanted with a 4196 lead was 170. Some data was not reported and deviations were recorded.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4196 Lead | Subjects underwent Model 4196 left ventricular lead implant attempt |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.
| Implant |
| All Left Ventricular Leads | All left ventricular leads successfully implanted | Implant |
| All Medtronic Left Ventricular Leads (Attain Family) | All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted | Implant |
| Cannulation Time | Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation. | Implant |
| Fluoroscopy Time | Fluoroscopy time was defined as the total time the fluoroscope was imaging. | Implant |
| Model 4196 Lead Placement Time | Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location. | Implant |
| Total Implant Time | Total implant time was defined as time from initial incision to final closure. | Implant |
| Assessment of Lead Handling Characteristics | Lead handling characteristics assessed as "acceptable" by physicians | Implant |
| Electrical Performance - Tip Electrode: Sensing | Model 4196 lead tip electrode R-wave amplitude | 12-month |
| Electrical Performance - Tip Electrode: LV Voltage Threshold | Model 4196 lead tip electrode LV voltage threshold | 12-month |
| Electrical Performance -Tip Electrode: Pacing Impedance | Model 4196 lead tip electrode pacing impedance | 12-month |
| Electrical Performance -Ring Electrode: Sensing | Model 4196 lead ring electrode R-wave amplitude | Implant |
| Electrical Performance - Ring Electrode: LV Voltage Threshold | Model 4196 lead ring electrode LV voltage threshold | 12-month |
| Electrical Performance -Ring Electrode: Pacing Impedance | Model 4196 lead ring electrode pacing impedance | 12-Month |
| Summarize All Adverse Events | All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu | Up to 18 months |
| Phoenix |
| Arizona |
| United States |
| Long Beach | California | United States |
| Palo Alto | California | United States |
| Davenport | Iowa | United States |
| Lexington | Kentucky | United States |
| Baton Rouge | Louisiana | United States |
| Detroit | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Kansas City | Missouri | United States |
| Raleigh | North Carolina | United States |
| Mayfield Heights | Ohio | United States |
| Wynnewood | Pennsylvania | United States |
| Spartanburg | South Carolina | United States |
| Kingsport | Tennessee | United States |
| Memphis | Tennessee | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Burlington | Vermont | United States |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Sainte-Foy | Quebec | Canada |
| Implant Attempted |
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| Model 4196 Lead Attempted |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 4196 Lead | Subjects underwent Model 4196 left ventricular lead implant attempt |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All subjects who underwent an implant attempt (186) were included in the study population analyses. | Count of Participants | Participants |
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| Age Continuous | All subjects who underwent an implant attempt (186) were included in the study population analyses. | Mean | Standard Deviation | years |
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| Sex: Female, Male | All subjects who underwent an implant attempt (186) were included in the study population analyses. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| New York Heart Association | All subjects who underwent an implant attempt (186) were included in the study population analyses. Some subjects did not report data or data was outside the criteria, this was captured as a protocol deviation. | Number | Participants |
| ||||||||||||||||||||||
| Race / Ethnicity | All subjects who underwent an implant attempt (186) were included in the study population analyses. | Number | Participants |
| ||||||||||||||||||||||
| Intrinsic QRS Width | All subjects who underwent an implant attempt (186) were included in the study population analyses. Some subjects did not report data or data was outside the criteria, this was captured as a protocol deviation. | Mean | Standard Deviation | Milliseconds |
| |||||||||||||||||||||
| Left Ventricular Ejection Fraction | All subjects who underwent an implant attempt (186) were included in the study population analyses. Some subjects did not report data or data was outside the criteria, this was captured as a protocol deviation. Left ventricular ejection fraction is the fraction of blood pumped out of the left ventricle with each heartbeat. For this measurement, the fraction is presented as a percent. | Mean | Standard Deviation | Percent |
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| 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 | Safety (Subjects Without a Model 4196 Lead Related Complication) | A subject who was free of a Model 4196 lead related complication by one month visit. | Subjects who underwent a Model 4196 left ventricular (LV) lead implant attempt and completed 1-month visit; or experienced Model 4196 lead related complications by 1-month visit. | Posted | Apr 2009 | Number | participants | One Month |
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| Secondary | Subjects Successfully Implanted With Model 4196 Lead | A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately. | Subjects who underwent Model 4196 lead implant attempt. | Posted | Apr 2009 | Number | participants | Implant |
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| Primary | Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) | Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms]) | Subjects with pacing threshold at tip electrode captured at 0.5 milliseconds (ms) at 1-month visit. | Posted | Mean | Standard Deviation | volts | One Month |
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| Primary | Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) | Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms]) | Subjects with pacing threshold at ring electrode captured at 0.5 milliseconds (ms) at 3-month visit. | Posted | Mean | Standard Deviation | volts | Three Months |
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| Secondary | Subjects Successfully Implanted After Cannulation | A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately. | Subjects with successful CS cannulation after an incision was made (implant attempt) | Posted | Number | participants | Implant |
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| Secondary | All Left Ventricular Leads | All left ventricular leads successfully implanted | Subjects who underwent an implant attempt. | Posted | Number | participants | Implant |
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| Secondary | All Medtronic Left Ventricular Leads (Attain Family) | All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted | Subjects who underwent an implant attempt. | Posted | Apr 2009 | Number | participants | Implant |
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| Secondary | Cannulation Time | Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation. | Subjects successfully implanted with a Model 4196 lead. | Posted | Mean | Standard Deviation | minutes | Implant |
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| Secondary | Fluoroscopy Time | Fluoroscopy time was defined as the total time the fluoroscope was imaging. | Subjects successfully implanted with a Model 4196 lead. | Posted | Mean | Standard Deviation | minutes | Implant |
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| Secondary | Model 4196 Lead Placement Time | Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location. | Subjects successfully implanted with a Model 4196 lead. | Posted | Mean | Standard Deviation | minutes | Implant |
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| Secondary | Total Implant Time | Total implant time was defined as time from initial incision to final closure. | Subjects successfully implanted with a Model 4196 lead. | Posted | Mean | Standard Deviation | minutes | Implant |
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| Secondary | Assessment of Lead Handling Characteristics | Lead handling characteristics assessed as "acceptable" by physicians | All available assessments from physicians. | Posted | Number | participants | Implant |
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| Secondary | Electrical Performance - Tip Electrode: Sensing | Model 4196 lead tip electrode R-wave amplitude | Subjects with Model 4196 lead implanted and an intrinsic R-wave available at 12-month visit. | Posted | Mean | Standard Deviation | millivolt (mV) | 12-month |
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| Secondary | Electrical Performance - Tip Electrode: LV Voltage Threshold | Model 4196 lead tip electrode LV voltage threshold | Subjects with Model 4196 lead implanted and 12-month visit completed. | Posted | Mean | Standard Deviation | Volts | 12-month |
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| Secondary | Electrical Performance -Tip Electrode: Pacing Impedance | Model 4196 lead tip electrode pacing impedance | Subjects with Model 4196 lead implanted and 12-month visit completed. | Posted | Mean | Standard Deviation | Ohms | 12-month |
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| Secondary | Electrical Performance -Ring Electrode: Sensing | Model 4196 lead ring electrode R-wave amplitude | Subjects with Model 4196 lead implanted and with intrinsic R-wave amplitude at implant. | Posted | Mean | Standard Deviation | mV | Implant |
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| Secondary | Electrical Performance - Ring Electrode: LV Voltage Threshold | Model 4196 lead ring electrode LV voltage threshold | Subjects with Model 4196 lead implanted and 12-month visit completed. | Posted | Mean | Standard Deviation | Volts | 12-month |
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| Secondary | Electrical Performance -Ring Electrode: Pacing Impedance | Model 4196 lead ring electrode pacing impedance | Subjects with Model 4196 lead implanted and completed 12-month visit. | Posted | Mean | Standard Deviation | Ohms | 12-Month |
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| Secondary | Summarize All Adverse Events | All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu | All subjects enrolled into the 4196 study. | Posted | Number | adverse events | Up to 18 months |
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Generally, contracts allow investigators to publish study results per the protocol and publication plan. Medtronic reviews publications to determine if confidential information ("CI") is included. Any such CI is deleted before publication. Medtronic may not censor/interfere with the publication. Investigators may publish single-site publications after a decision by Medtronic that no multi-site study publication will be done or 12 months after the study is closed, whichever is earlier.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hang Nguyen | Medtronic CRDM Clinical Research | 800-328-2518 | 62832 | hang.t.nguyen@medtronic.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Black or African American |
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| Columbian |
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| Hispanic or Latino |
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| Native Hawaiian or Pacific Islander |
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| Sri Lankan |
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| Subject chose not to provide |
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| White |
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