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Inability to reach statistical significance toward primary endpoint
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). The study will compare how much time either ICD wire is used by the ICD and the status of congestive heart failure.
Recent research supports the hypothesis that reducing the amount of pacing in the lower right chamber of the heart may prevent the progression of congestive heart failure (CHF) in some implantable cardioverter defibrillator (ICD) patients. CHF refers to symptoms (shortness of breath, fatigue, fluid overload) caused by decreased pumping action of the heart muscle. The ICD can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). Both settings allow the heart to beat more naturally using its own electrical signals. Two device settings will be compared. Managed ventricular pacing (MVP) will allow the ICD to use both wires only as necessary. This setting allows the ICD to send electrical signals to the top and bottom chambers of the heart if needed. The other setting, ventricular pacing (VVI) will allow the ICD to operate the bottom chamber of the heart if it is needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVI 40 pacing | Active Comparator | Backup ventricular pacing (VVI) at 40 beats per minute |
|
| MVP pacing | Active Comparator | Managed ventricular pacing (MVP) at 60 beats per minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD (Implantable Cardioverter Defibrillator) | Device | VVI 40 vs. MVP |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations. | A composite endpoint of all cause mortality and HF hospitalizations or urgent care. (Emergency Department, Urgent Clinic visits, or hospitalizations wiht intravenous medications for HF) | Enrollment to last visit (up to 45 months post-randomization) or death |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Worsening Heart Failure-related Adverse Events | HF event meeting primary endpoint definition, or adverse events associated with, but not limited to, any of the following: symptoms or physical signs compatible with worsening HF, laboratory evidence of HF, any modification of oral heart failure therapy | Enrollment to last visit (up to 45 months post-randomization) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael O Sweeney | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage | Alaska | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20685401 | Derived | Sweeney MO, Ellenbogen KA, Tang AS, Whellan D, Mortensen PT, Giraldi F, Sandler DA, Sherfesee L, Sheldon T; Managed Ventricular Pacing Versus VVI 40 Pacing Trial Investigators. Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Nov;7(11):1552-60. doi: 10.1016/j.hrthm.2010.05.038. Epub 2010 Jun 4. |
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2051 subjects were screened for the study. Of the 2051 subjects screened, 1037 were enrolled in the study. 6 of 1037 subjects later failed to meet other qualifying inclusion criteria and were not randomized and assigned to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | VVI 40 Pacing | Backup ventricular pacing at a rate of 40 beats per minute |
| FG001 | MVP Pacing | Managed Ventricular Pacing at a rate of 60 beats per minute |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time | NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst. | Baseline, 12, 24 and 36 month visits |
| Heart Chamber Dimensions and Wall Thicknesses | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits |
| Left Ventricular (LV) Ejection Fraction and Fractional Shortening | Echocardiogram measures for each endpoint were obtained at multiple time points. LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%. LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%. | Baseline, 12, and 24 month visits |
| Left Ventricular (LV) and Left Atrial (LA) Volumes | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits |
| Left Ventricular (LV) Sphericity Index | Echocardiogram measures for each endpoint were obtained at multiple time points. LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis. | Baseline, 12, and 24 month visits |
| Hemodynamic Velocity Measures | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits |
| Hemodynamic Deceleration Time | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits |
| Left Atrial (LA) and Mitral Regurgitation (MR) Areas | Echocardiogram measures for each endpoint were obtained at multiple time points. | Baseline, 12, and 24 month visits |
| Composite Mitral Regurgitation (MR) Severity Score | Echocardiogram measures for this endpoint were obtained at multiple time points. Composite MR Severity was measured on a scale of "None to Trivial" to "Grade IV", with Grade IV being the worst possible score and "None to Trivial" being the best possible score. | Baseline, 12, and 24 month visits |
| Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes | Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF | Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization) |
| Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History | Persistent AF was defined as any of the following:
Clinically Important AF was defined as more than 20 hours of AT/AF in a single day | Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization) |
| Development of a Pacing Indication During the Study | Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective. | Enrollment to last visit (up to 45 months post-randomization) |
| Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction | Whether a subject is on each of a pre-specified set of drugs or classes of drugs. | Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months |
| Percent Ventricular Pacing | The percentage of a patients' ventricular beats that were paced by the device. | Enrollment, 6, 12, 24 and 36 month visits |
| Quality of Life ("QOL") Score | Minnesota Living with Heart Failure Questionnaire ("MLWHFQ") and Kansas City Cardiomyopathy Questionnaire ("KCCQ") Quality of Life("QOL") Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline. Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best) | Baseline, 12, 24, and 36 month visits |
| All Cause Mortality | Death from any cause | Enrollment to last visit (up to 45 months post-randomization) or death |
| ICD-indicated Patients With Class I Pacemaker Indication. | Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant | Period of time prior to patient consent when considering patient for Implant/Enrollment |
| Little Rock |
| Arkansas |
| United States |
| North Little Rock | Arkansas | United States |
| Brandon | Florida | United States |
| Clearwater | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Naples | Florida | United States |
| Pensacola | Florida | United States |
| Atlanta | Georgia | United States |
| Savannah | Georgia | United States |
| Indianapolis | Indiana | United States |
| Des Moines | Iowa | United States |
| Kansas City | Kansas | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Baltimore | Maryland | United States |
| Silver Spring | Maryland | United States |
| Takoma Park | Maryland | United States |
| Detroit | Michigan | United States |
| Lansing | Michigan | United States |
| Marquette | Michigan | United States |
| Petoskey | Michigan | United States |
| Coon Rapids | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| St Louis | Missouri | United States |
| Lebanon | New Hampshire | United States |
| Hackensack | New Jersey | United States |
| Newark | New Jersey | United States |
| New Hyde Park | New York | United States |
| New York | New York | United States |
| Gastonia | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Mayfield Hts. | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Tulsa | Oklahoma | United States |
| Allentown | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Knoxville | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Taylorville | Utah | United States |
| Charlottesville | Virginia | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Morgantown | West Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Sankt Pölten | Austria |
| Edmonton | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Victoria | British Columbia | Canada |
| Ottawa | Ontario | Canada |
| Montreal | Quebec | Canada |
| Ste-Foy | Quebec | Canada |
| Aarus | Denmark |
| Le Chesnay | France |
| Lille | France |
| Bad Berka | Germany |
| Franfurt Am Main | Germany |
| Heidelberg | Germany |
| Homburg/Saar | Germany |
| Kiel | Germany |
| Haifa | Israel |
| Milano | Israel |
| Tel Aviv | Israel |
| Milan | Italy |
| Tromsø | Norway |
| Valencia | Spain |
| Zurich | Switzerland |
| London | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VVI 40 Pacing | Backup ventricular pacing at a rate of 40 beats per minute |
| BG001 | MVP Pacing | Managed Ventricular Pacing at a rate of 60 beats per minute |
| BG002 | Total | Total of all reporting groups |
| 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 | All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure ("HF") Hospitalizations. | A composite endpoint of all cause mortality and HF hospitalizations or urgent care. (Emergency Department, Urgent Clinic visits, or hospitalizations wiht intravenous medications for HF) | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Number | events | Enrollment to last visit (up to 45 months post-randomization) or death |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Worsening Heart Failure-related Adverse Events | HF event meeting primary endpoint definition, or adverse events associated with, but not limited to, any of the following: symptoms or physical signs compatible with worsening HF, laboratory evidence of HF, any modification of oral heart failure therapy | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Number | participants/events | Enrollment to last visit (up to 45 months post-randomization) |
|
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| Secondary | Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time | NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Number | participants | Baseline, 12, 24 and 36 month visits |
|
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| Secondary | Heart Chamber Dimensions and Wall Thicknesses | Echocardiogram measures for each endpoint were obtained at multiple time points. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | centimeters (cm) | Baseline, 12, and 24 month visits |
|
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| Secondary | Left Ventricular (LV) Ejection Fraction and Fractional Shortening | Echocardiogram measures for each endpoint were obtained at multiple time points. LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%. LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | percentage of LV unit | Baseline, 12, and 24 month visits |
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| Secondary | Left Ventricular (LV) and Left Atrial (LA) Volumes | Echocardiogram measures for each endpoint were obtained at multiple time points. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | milliliters (mL) | Baseline, 12, and 24 month visits |
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| Secondary | Left Ventricular (LV) Sphericity Index | Echocardiogram measures for each endpoint were obtained at multiple time points. LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | Ratio | Baseline, 12, and 24 month visits |
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| Secondary | Hemodynamic Velocity Measures | Echocardiogram measures for each endpoint were obtained at multiple time points. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | meters per second (m/s) | Baseline, 12, and 24 month visits |
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| Secondary | Hemodynamic Deceleration Time | Echocardiogram measures for each endpoint were obtained at multiple time points. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | milliseconds (ms) | Baseline, 12, and 24 month visits |
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| Secondary | Left Atrial (LA) and Mitral Regurgitation (MR) Areas | Echocardiogram measures for each endpoint were obtained at multiple time points. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | centimeters squared (cm2) | Baseline, 12, and 24 month visits |
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| Secondary | Composite Mitral Regurgitation (MR) Severity Score | Echocardiogram measures for this endpoint were obtained at multiple time points. Composite MR Severity was measured on a scale of "None to Trivial" to "Grade IV", with Grade IV being the worst possible score and "None to Trivial" being the best possible score. | Posted | Number | participants | Baseline, 12, and 24 month visits |
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| Secondary | Occurrence of Ventricular Tachycardia ("VT") and Ventricular Fibrillation ("VF") Episodes | Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Number | Annualized Episodes per Patient Month | Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization) |
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| Secondary | Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History | Persistent AF was defined as any of the following:
Clinically Important AF was defined as more than 20 hours of AT/AF in a single day | 1 of 1031 randomized subjects had a history of at least 6 months of chronic AF, which was an exclusion criterion. Of the remaining 1030 randomized subjects that met all inclusion criteria, only those with no history of AF were included in the analysis (445 in the VVI 40 arm and 444 in the MVP arm). An intention to treat analysis was performed. | Posted | Number | participants | Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Development of a Pacing Indication During the Study | Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Number | participants | Enrollment to last visit (up to 45 months post-randomization) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Medication Usage Affecting Heart Rate and Atrioventricular ("AV") Conduction | Whether a subject is on each of a pre-specified set of drugs or classes of drugs. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Number | Percentage of Subjects | Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months |
|
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| Secondary | Percent Ventricular Pacing | The percentage of a patients' ventricular beats that were paced by the device. | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | Percent pacing | Enrollment, 6, 12, 24 and 36 month visits |
|
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| Secondary | Quality of Life ("QOL") Score | Minnesota Living with Heart Failure Questionnaire ("MLWHFQ") and Kansas City Cardiomyopathy Questionnaire ("KCCQ") Quality of Life("QOL") Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline. Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best) | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 12, 24, and 36 month visits |
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| Secondary | All Cause Mortality | Death from any cause | 1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation ("AF"), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective. | Posted | Number | participants who died | Enrollment to last visit (up to 45 months post-randomization) or death |
|
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| Secondary | ICD-indicated Patients With Class I Pacemaker Indication. | Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant | Centers kept a screening log, recording for each patient considered for new ICD implant and possible trial enrollment whether the patient had a Class I pacing indication at time of implant. The analysis consisted of descriptive statistics (counts of the 2051 screened patients). | Posted | Number | participants | Period of time prior to patient consent when considering patient for Implant/Enrollment |
|
|
From enrollment to study exit or closure (up to 45 months post-randomization)
Adverse Events defined as any undesirable clinical occurrence in a subject. Data collection limited to cardiovascular, pulmonary or renal system (including system and procedure-related events) or events in which the subject presented with symptoms compatible with fluid retention and/or decreased exercise tolerance.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VVI 40 Pacing | Backup ventricular pacing at a rate of 40 beats per minute | 128 | 513 | 116 | 513 | ||
| EG001 | MVP Pacing | Managed Ventricular Pacing at a rate of 60 beats per minute | 121 | 518 | 113 | 518 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic Shock | General disorders | Systematic Assessment |
| ||
| Cerebellar Hematoma | General disorders | Systematic Assessment |
| ||
| Cerebral Hemorrhage | General disorders | Systematic Assessment |
| ||
| Chronic Obstructive Pulmonary Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic Obstructive Pulmonary Disorder with Renal Failure | General disorders | Systematic Assessment |
| ||
| Closed Head Trauma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Acute Respiratory Distress Syndrome | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Anemia | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Angina | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Bronchitis | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Cellulitis and Anemia | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Chronic Obstructive Pulmonary Disease | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Coronary Artery Disease | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Coronary Artery Disease and Atrial Fibrillation | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Coronary Artery Disease, SVT and VT | General disorders | Systematic Assessment | Congestive Heart Failure with Coronary Artery Disease, Supraventricular Tachycardia (SVT) and Ventricular Tachycardia (VT) |
| |
| Congestive Heart Failure with Infection - Respiratory Tract | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Myocardial Infarction and Renal Failure | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Pneumonia | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Pneumonia and Renal Failure | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Pneumothorax and Right Atrial Lead Dislodgement | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Renal Failure | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Stroke | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure with Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Disease | Vascular disorders | Systematic Assessment |
| ||
| Coronary Artery Disease with Ventricular Tachycardia | General disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Gastrointestinal Bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyperkalemia | General disorders | Systematic Assessment |
| ||
| Hypokalemia | General disorders | Systematic Assessment |
| ||
| Hypotension | General disorders | Systematic Assessment |
| ||
| Increased Right Ventricular Lead Impedance | General disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Infection - Device, Leads | Infections and infestations | Systematic Assessment |
| ||
| Infection - Incision Site | Infections and infestations | Systematic Assessment |
| ||
| Infection - Pocket | Infections and infestations | Systematic Assessment |
| ||
| Infection - Systemic | Infections and infestations | Systematic Assessment |
| ||
| Infection - Urinary Tract | Infections and infestations | Systematic Assessment |
| ||
| Lead Dislodgement - Right Ventricular Lead | General disorders | Systematic Assessment |
| ||
| Lead Fracture - Right Ventricular Lead | General disorders | Systematic Assessment |
| ||
| Lead Perforation - Right Ventricular Lead | General disorders | Systematic Assessment |
| ||
| Lead Protrusion - Right Ventricular Lead | General disorders | Systematic Assessment |
| ||
| Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Leukemia - Myelogenous | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Medication Allergy | General disorders | Systematic Assessment |
| ||
| Metabolic Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction with Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Necrosis - Left Lower Extremity | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pantocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Peripheral Vascular Disease | Vascular disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural Effusion with Renal Failure and Sepsis | General disorders | Systematic Assessment |
| ||
| Pneumonia | General disorders | Systematic Assessment |
| ||
| Pneumonia with Myocardial Infarction | General disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Premature Battery Depletion | General disorders | Systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Embolus | General disorders | Systematic Assessment |
| ||
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure with Pneumonia and Atrial Fibrillation | General disorders | Systematic Assessment |
| ||
| Sepsis | General disorders | Systematic Assessment |
| ||
| Sleep Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Stroke | General disorders | Systematic Assessment |
| ||
| Subdural Hematoma | General disorders | Systematic Assessment |
| ||
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Tachycardia and Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigational 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MVP Clinical Trial Leader | Medtronic, Inc. | medtroniccrmtrials@medtronic.com |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| United States |
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| Canada |
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| Spain |
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| Austria |
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| Denmark |
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| Israel |
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| Germany |
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| United Kingdom |
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| Switzerland |
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| Italy |
|
| Yes |
| Non-Inferiority or Equivalence |
A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.21. The one-sided upper confidence bound for the hazard ratio had to be less than 1.21 for the null hypothesis to be rejected. The threshold of 1.21 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month event-free rates. |
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