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Lower enrollment rate than expected
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
Traditionally clinicians program the safety margins for the right atrial, right ventricular, and left ventricular leads two-times the capture thresholds. This safety margin is necessary for the right atrial and right ventricular outputs to prevent asystole during fluctuation of capture thresholds. This two-times safety margin may not be necessary for the left ventricular lead output and may be causing shorter device battery longevity. Newly implemented LV capture threshold management algorithms may help maintain a proper balance of safety margin and battery longevity. However, recent research conducted on automatic left ventricular capture measurement (LVCM) shows as much as 3.5 V daily variability in capture thresholds. In this same study, 18% of patients had >1.5 V LV threshold variability. A possible explanation for the variability of LV thresholds is lead stability. Small movements of the lead electrodes associated with movement of patient posture may account for daily fluctuation of capture thresholds. As heart failure patient care and therapies improve, CRT patients may survive longer than the projected longevities of their device. In order to minimize patient risks associated with device change-outs, care must be taken to maximize battery longevity while maintaining CRT pacing. Examining patient posture changes as a possible cause of threshold variability may guide clinicians to program more appropriate LV outputs with patient safety and device longevity in mind.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic passive fixation LV lead | Experimental | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule |
|
| Medtronic 4195 Active Fixation LV Lead | Experimental | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead | Device | 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Change in Threshold of >1 Volt With Posture Changes | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James B DeVille, M.D. | Baylor Research Institute - The Heart Hospital Baylor Plano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Hospital in Plano | Plano | Texas | 75093 | United States |
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Patients required at physician office. Recruiting will be active until 40 patients are randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medtronic Passive Fixation LV Lead | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. |
| FG001 | Medtronic 4195 Active Fixation LV Lead | Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medtronic Passive Fixation LV Lead | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 | Evidence of Change in Threshold of >1 Volt With Posture Changes | Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis. | Posted | 6 months |
|
1 year
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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 | Medtronic 4195 Active Fixation LV Lead | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pre-existing AF-AVNode ABL | Cardiac disorders | Systematic Assessment |
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Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Manager | The Heart Hospital Baylor Plano | 469-814-4712 | natalie.settele@baylorhealth.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Lack of Efficacy |
|
| BG001 | Medtronic 4195 Active Fixation LV Lead | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule. Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. |
|
| 3 |
| 11 |
| 0 |
| 11 |
| EG001 | Medtronic Passive Fixation LV Lead | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. | 0 | 0 | 0 | 0 |
| Enteroccoccal Septicemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| LV lead dislodgement | Cardiac disorders | Systematic Assessment |
|
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