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| ID | Type | Description | Link |
|---|---|---|---|
| IDE # G080060 | Other Identifier | FDA | |
| Doc number 40005027 | Other Identifier | St. Jude Medical |
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This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices. These new ICD and CRT-D devices have new features that allow the device to periodically check how much energy is needed to pace a patient's heart and to automatically adjust the amount of energy used to pace the heart.
All patients enrolled in the study will have their device tested to determine if the device can automatically measure how much energy is needed to pace the patient's heart. If the test is successful, the patient's device will be programmed to turn that feature on. 3 months after enrollment, the patient will return to the clinic to have their device re-tested using an automatic test method to measure the amount of energy needed to make the patient's heart beat. A manual test method will also be used to measure the amount of energy needed to make the patient's heart beat. The intent of the study is to show the automatic method works just as well as the manual method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promote RF CRT-D | Experimental | Patients with CRT-D device will have the autocapture features of the device tested. |
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| Current RF ICD | Experimental | Patients with ICD device will have the autocapture features of the device tested. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing of the autocapture features of the device | Device | Patients receiving cardiac resynchronization therapy will have new autocapture features tested on right atrial, right ventricular and left ventricular leads. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Free of System-related Complications at 3-months Post Implant | 3 months post implant | |
| Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test | Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG. | 3 months post implant |
| Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test | Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG. | 3 months post implant |
| Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test | Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Shipman | Director, Clinical Affairs, St. Jude Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkanasas Heart Hospital | Little Rock | Arkansas | 72211 | United States | ||
| Baptist Health Hospital |
All patients who were enrolled in the study had the autocapture feature tested at each study visit, starting with at the implant visit when the study device was implanted.
Recruitment began in August 2008 at hospitals where patients were being implanted with implantable cardioverter defibrillators or in and physician offices where these patients were being followed. Recruitment was completed on April 1, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | CRT-D Device Patients | All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study. |
| FG001 | ICD Device Patients | All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Testing of the autocapture features of the device | Device | Patients with an Implantable Cardioverter Defibrillator will have new autocapture features tested on the right atrial and right ventricular leads. |
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| 3 months post implant |
| Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test | Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG. | 3 months post implant |
| Little Rock |
| Arkansas |
| 73305 |
| United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| St. Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| Southwest Texas Methodist Hospital | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients enrolled in the study |
| 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 | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Cardiomyopathy | Number | Participants |
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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 | Percentage of Participants Free of System-related Complications at 3-months Post Implant | Posted | Nov 2010 | Number | Percentage of Participants | 3 months post implant |
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| Primary | Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test | Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG. | Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold test were included in this analysis. | Posted | Nov 2010 | Mean | Standard Deviation | Volts | 3 months post implant |
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| Primary | Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test | Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG. | Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold test were included in this analysis. | Posted | Nov 2010 | Mean | Standard Deviation | Volts | 3 months post implant |
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| Primary | Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test | Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG. | Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle were included in this analysis. | Posted | Nov 2010 | Mean | Standard Deviation | Volts | 3 months post implant |
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| Primary | Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test | Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG. | Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle were included in the analysis. | Posted | Mean | Standard Deviation | Volts | 3 months post implant |
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9 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 | All patients enrolled in the study | 0 | 128 | 33 | 128 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ecchymosis at implant site | Surgical and medical procedures | Non-systematic Assessment | Adverse events are reported as either a complication or observation (1), defined as an adverse event that requires invasive intervention or an adverse event that can be managed without invasive intervention, respectively. |
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| hematoma | Surgical and medical procedures | Non-systematic Assessment | 7 observations |
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| LV lead dislodgement | Surgical and medical procedures | Non-systematic Assessment | 1 complication |
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| pericardial tamponade | Surgical and medical procedures | Non-systematic Assessment | 1 complication |
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| erroneous elective replacement alert | Surgical and medical procedures | Non-systematic Assessment | 3 observations |
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| high defibrillation thresholds | Cardiac disorders | Non-systematic Assessment | 1 observation |
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| infection | Surgical and medical procedures | Non-systematic Assessment | 1 complication, 1 observation |
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| suspected set screw malfunction | Surgical and medical procedures | Non-systematic Assessment | 1 complication |
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| suspected generator malfunction | Surgical and medical procedures | Non-systematic Assessment | 1 complication |
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| elevated pacing thresholds - RA lead | Cardiac disorders | Non-systematic Assessment | 1 observation |
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| elevated pacing thresholds - RV lead | Cardiac disorders | Non-systematic Assessment | 1 complication, 1 observation |
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| elevated pacing threshold - LV lead | Cardiac disorders | Non-systematic Assessment | 9 observations, 9 pts |
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| lead dislodgement/migration - RA lead | Surgical and medical procedures | Non-systematic Assessment | 2 complications - 2 pts |
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| lead dislodgement/migration - RV lead | Surgical and medical procedures | Non-systematic Assessment | 1 complication |
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| lead dislodgement/migration - LV lead | Surgical and medical procedures | Non-systematic Assessment | 4 complications, 3 pts |
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| lead insulation damage - RV lead | Surgical and medical procedures | Non-systematic Assessment | 1 complication |
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| phrenic nerve/diaphragmatic stimulation - LV lead | Surgical and medical procedures | Non-systematic Assessment | 4 observations, 1 complication |
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| RA and RV lead dislodgement/migration | Surgical and medical procedures | Non-systematic Assessment | 1 observation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashish Oza, Clinical Studies Director | St. Jude Medical | 818 362 6822 | 3648 | aoza@sjm.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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