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The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.
The primary endpoint of the study is to measure prospectively at 6 months the percentage of responder* patients implanted with a Quartet LV quadripolar lead and with the MultiPoint Pacing feature activated compared with No Pacing at baseline.
*A positive CRT response is defined as an improvement of more than 15 % in Left Ventricular End Systolic Volume (LVESV) at 6 months post-implant, measured by Echocardiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPP ON | Experimental | To activate the Multipoint Pacing (MPP) feature to ON in all patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPP ON | Device | Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated |
| Measure | Description | Time Frame |
|---|---|---|
| Number of CRT Responders | The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of >15 % in LVESV, as measured by echocardiography. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in LV Echocardiographic Parameters | An echocardiogram was performed at baseline and at 6 months in subjects with MPP activated. The outcome evaluated the percentage of change in LVESV, left ventricular end-diastolic volume (LVEDV), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) as compared to baseline prior to implant. The values of change with positive numbers represent increases and negative numbers represent decreases. |
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Inclusion Criteria:
Exclusion Criteria:
Already has a CRT device implanted.
Myocardial Infarction or unstable angina within 40 days prior the enrollment.
New York Heart Association (NYHA) Class IV
Recent cardiac revascularization in the 4 weeks prior to enrollment.
Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment.
Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months.
Primary valvular disease requiring surgical intervention.
Atrial Fibrillation (AF):
Patient for whom suitable Transthoracic echocardiographic images for determining the cardiac output (CO) and LV volumes cannot be obtained.
Undergone a cardiac transplantation or being waiting for it
Life expectancy < 6 months
Pregnancy or planning to become pregnant
Unable to comply with the follow up schedule
Currently participating in any other clinical investigation.-
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| Name | Affiliation | Role |
|---|---|---|
| Oscar Sanz | Abbott Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de la Victoria | Málaga | Spain |
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Subject enrollment began on 11-Feb-2016 and the last enrollment occurred on 13-Aug-2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | MPP ON | Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead will be programmed with the MultiPoint Pacing (MPP) feature activated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MPP ON | MPP ON: Subjects implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of CRT Responders | The number of CRT responders was evaluated at 6 months post-implant. A CRT responder patient was a patient with an improvement of >15 % in LVESV, as measured by echocardiography. | The analysis population included subjects implanted with a Quartet LV quadripolar lead and with the MPP feature activated and who had a 6-month CRT response evaluation via echocardiography. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit, or had relevant 6-month data missing were excluded from the analysis. | Posted | Count of Participants | Participants | 6 months |
|
6 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 | Total Enrolled | All subjects enrolled in the study are included in the outcome measure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Arrhytmia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pilar Santamaria | Abbott Medical | +34 917 278 964 | pilar.santamaria@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2015 | Apr 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline and 6 months |
| Number of CRT Super-responders | The outcome evaluated the number of CRT super-responders at 6 months in subjects with MPP activated. A super-responder is defined as a subject with a mean absolute LVEF increase of >14% at 6 months post-implant compared to baseline. | 6 months |
| Rates of Hospitalization and Mortality | The outcome measures rates of all-cause mortality, all-cause hospitalization, cardiovascular hospitalization, and heart failure hospitalization. In addition, the outcome measures the combined endpoint of mortality and heart failure hospitalization and mortality and cardiovascular hospitalization. For the combined endpoints, if a participant experienced both endpoints, they were counted as one participant. | 6 months |
| Change in NYHA Classification | The outcome measures status changes in NYHA classification at 6 months for subjects with MPP activated. Subjects experienced either an improvement, worsening, or no change in NYHA classification. The NYHA provides a simple way of classifying the extent of heart failure: NYHA I: No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation, dyspnea. NYHA II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. | 6 months |
| Death |
|
| Lost to Follow-up |
|
| MPP programmed to OFF |
|
| Withdrawal by Subject |
|
| Unsuccessful implant |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Left Ventricular End Systolic Volume (LVESV) | The number of subjects in this analysis population differs from the overall study population because LVESV was only calculated in the 77 analyzable subjects with 6-month echocardiogram data available. | Mean | Standard Deviation | mililiters |
|
| New York Heart Association (NYHA) Classification | The NYHA provides a simple way of classifying the extent of heart failure: NYHA I: No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation, dyspnea. NYHA II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. | Count of Participants | Participants |
|
| Cardiomyopathy Etiology | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Changes in LV Echocardiographic Parameters | An echocardiogram was performed at baseline and at 6 months in subjects with MPP activated. The outcome evaluated the percentage of change in LVESV, left ventricular end-diastolic volume (LVEDV), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) as compared to baseline prior to implant. The values of change with positive numbers represent increases and negative numbers represent decreases. | The analysis population included subjects implanted with a Quartet LV quadripolar lead and with the MPP feature activated and who had a 6-month CRT response evaluation via echocardiography. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit, or had relevant 6-month data missing were excluded from the analysis. | Posted | Mean | Standard Deviation | Percent change | Baseline and 6 months |
|
|
|
| Secondary | Number of CRT Super-responders | The outcome evaluated the number of CRT super-responders at 6 months in subjects with MPP activated. A super-responder is defined as a subject with a mean absolute LVEF increase of >14% at 6 months post-implant compared to baseline. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Rates of Hospitalization and Mortality | The outcome measures rates of all-cause mortality, all-cause hospitalization, cardiovascular hospitalization, and heart failure hospitalization. In addition, the outcome measures the combined endpoint of mortality and heart failure hospitalization and mortality and cardiovascular hospitalization. For the combined endpoints, if a participant experienced both endpoints, they were counted as one participant. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Change in NYHA Classification | The outcome measures status changes in NYHA classification at 6 months for subjects with MPP activated. Subjects experienced either an improvement, worsening, or no change in NYHA classification. The NYHA provides a simple way of classifying the extent of heart failure: NYHA I: No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation, dyspnea. NYHA II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. NYHA III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. NYHA IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. | Subjects implanted with a CRT-D device and a Quartet quadripolar LV lead, programmed with the MPP feature activated and who had a NYHA classification evaluation at baseline and 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 2 |
| 105 |
| 16 |
| 105 |
| 11 |
| 105 |
| Coronary Artery Disease | Cardiac disorders | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Exacerbation of Heart Failure | Cardiac disorders | Non-systematic Assessment |
|
| Trauma | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Inappropriate shock | Cardiac disorders | Non-systematic Assessment |
|
| Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Lead dislodgment | Cardiac disorders | Non-systematic Assessment |
|
| Pneumothorax/Hemothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Subclavian Vein Thrombus | Cardiac disorders | Non-systematic Assessment |
|
| Twiddler´s Syndrome | Cardiac disorders | Non-systematic Assessment |
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| Ventricular Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Hematoma/Seratoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Inappropiate shock | Cardiac disorders | Non-systematic Assessment |
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| Intermittent pacing | Cardiac disorders | Non-systematic Assessment |
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| Lead dislodgement | Cardiac disorders | Non-systematic Assessment |
|
| Oversensing | Cardiac disorders | Non-systematic Assessment |
|
| Pectoral/Diaphragmatic/Phrenic Nerve Stimulation | Cardiac disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| LVEDD |
|
| LVEF |
|
| Title | Measurements |
|---|---|
|
| Cardiovascular hospitalization |
|
| Combined mortality/heart failure hospitalization |
|
| Combined mortality/cardiovascular hospitalization |
|
| Title | Measurements |
|---|---|
|