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Resources unavailable to continue study follow-up.
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The purpose of this study is to determine if patients in the HeartNet Ventricular Support System with optimal medical and device therapy arm (Treatment group) show statistically significant improvement compared to patients in the optimal medical and device therapy alone arm (Control group) after 6 months of follow-up.
In the United States alone, more than five million people suffer from heart failure (CHF) and an estimated 400,000 to 700,000 new cases are diagnosed each year. Caused by a variety of cardiac conditions, systolic heart failire (HF) is the end-stage of heart disease where the heart is failing as a pump. Once diagnosed with the disease, less than 50% of the patients live for five years, and less than 25% survive for more than ten years. The number of deaths in the United States from this condition has more than doubled since 1979, averaging more than 250,000 annually.
Paracor Medical, Inc. has developed an elastic prosthetic wrap that is designed to apply a gentle mechanical support to the failing heart. The Implant is a compliant elastic structure that is designed to conform to the epicardial surface of the right and left ventricles. It supports the heart throughout the cardiac cycle and was designed to offload the ventricles and reduce wall stress.
The objective of this clinical trial is to evaluate the safety and efficacy of the HeartNet Ventricular Support System with optimal medical and device therapy (Treatment group) when compared to optimal medical and device therapy (i.e., medications, cardiac resynchronisation therapy, pacemaker) alone (Control group) as treatments for patients with heart failure.
Efficacy of the HeartNet Ventricular Support System in the Treatment group compared to the optimal medical and device therapy Control group will be evaluated based upon cardiopulmonary tests (Peak VO2), six (6) minute walk distance and quality of life assessment, as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire.
Safety of the HeartNet Ventricular Support System in the Treatment group compared to the Control group will be evaluated based on the all-cause mortality rate.
Paracor Medical intends to submit data obtained in this clinical trial to support a Pre-Market Approval Application to the United States Food and Drug Administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | HeartNet and Optimal Medical/Device Therapy (e.g., medications and cardiac resynchronisation therapy) |
|
| Control | Active Comparator | Optimal Medical/Device Therapy alone (e.g., medications and/or cardiac resynchronisation therapy) (Note: For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of angiotensin converting enzyme (ACE) inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy-defibrillator (CRT-D) for at least three months prior to study enrollment, when indicated.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartNet Ventricular Support System | Device | The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Analysis - Peak Oxygen Uptake (Peak VO2) | A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline. | Baseline to 6 months |
| Responder Analysis - Six (6) Minute Walk (6MW) Distance | A participant was considered a "responder" if 6MW distance at 6 months was at least 45 meters more than at baseline. | Baseline to 6 months |
| Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score. | baseline to 6 months |
| Number of Participant Deaths | Total number of participants who died within 12 months of enrollment into the trial. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in New York Heart Association (NYHA) Functional Class | Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remained the same as baseline. "Improved" means the participant's functional class improved (became lower in number) by at least one class. "Worsened" means the participant's functional class deteriorated (became higher in number) by at least one class. |
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Inclusion Criteria:
Specific Qualifying Characteristics
Exclusion Criteria:
Patient History
Surgical or Anatomical Considerations
Other
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| Name | Affiliation | Role |
|---|---|---|
| William T. Abraham, MD | Chief, Division of Cardiovascular Medicine, The Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| USC Keck School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23137493 | Derived | Abraham WT, Anand I, Aranda JM Jr, Boehmer J, Costanzo MR, DeMarco T, Holcomb R, Ivanhoe R, Kolber M, Rayburn B. Randomized controlled trial of ventricular elastic support therapy in the treatment of symptomatic heart failure: rationale and design. Am Heart J. 2012 Nov;164(5):638-45. doi: 10.1016/j.ahj.2012.07.015. Epub 2012 Oct 2. | |
| 20522572 |
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3 subjects were considered Roll-in (not randomized) and received treatment. Data from these subjects are not included in the results. Seven (7) subjects were randomized to the Treatment group but were not treated due to suspension of the study. These subjects are excluded from the data.
Subjects were recruited from 29 investigational sites in the US and 6 investigational sites in Canada, between November, 2006 to September, 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | HeartNet and Optimal Medical/Device Therapy |
| FG001 | Control | Optimal Medical/Device Therapy alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Optimal Medical/Device Therapy | Drug | Optimal Medical/Device Therapy - For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of ACE inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as CRT or CRT-D for at least three months prior to study enrollment, when indicated. |
|
|
| baseline to 6 months |
| Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented. | baseline to 6 months |
| Change in Left Ventricular Mass | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure. | baseline to 6 months |
| Responder Analysis - Peak Oxygen Uptake (Peak VO2) | A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline. | baseline to 12 months |
| Responder Analysis - Six (6) Minute Walk (6MW) Distance | A participant was considered a "responder" if 6MW distance at 12 months was at least 45 meters more than at baseline. | baseline to 12 Months |
| Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score. | baseline to 12 months |
| Heart Failure Hospitalization - Actuarial Analysis | Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment | 12 months |
| Change in Left Ventricular End Diastolic Volume | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure. | baseline to 6 months |
| Change in Left Ventricular End Systolic Volume | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure. | baseline to 6 months |
| Change in Ejection Fraction | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented. | baseline to 6 months |
| Change in Left Ventricular End Diastolic Diameter | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure. | baseline to 6 months |
| Change in Left Ventricular End Systolic Diameter | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure. | baseline to 6 months |
| Technical Success (Number of Treatment Arm Participants Successfully Implanted) | "Technical success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis. | 1 day |
| Heart Failure Death | Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure | 12 months |
| Heart Failure Death - Actuarial Analysis | Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure | 12 months |
| Heart Failure Hospitalization | Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment. | 12 months |
| All-Cause Hospitalization | Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis. | 12 months |
| All-Cause Hospitalization - Actuarial Analysis | Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations | 12 months |
| Participants Experiencing Serious Adverse Events | Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment | 12 months |
| Serious Adverse Events - Actuarial Analysis | Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events | 12 months |
| Days Alive Out of Hospital | Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis. | 12 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California, San Francisco, Medical Center | San Francisco | California | 94143 | United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Christiana Care Health System | Newark | Delaware | 19718 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Midwest Heart Foundation | Lombard | Illinois | 60148 | United States |
| St. Vincent Hospital and Health Services | Indianapolis | Indiana | 46260 | United States |
| Genesis Medical Center | Davenport | Iowa | 52803 | United States |
| University of Maryland, Division of Cardiology | Baltimore | Maryland | 21201 | United States |
| Caritas St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| Wayne State University/ Oakwood Hospital | Detroit | Michigan | 48201 | United States |
| Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 | United States |
| St. Paul Heart Clinic | Saint Paul | Minnesota | 55102 | United States |
| Mid America Heart Institute | Kansas City | Missouri | 64111 | United States |
| BryanLGH Heart Improvement Program | Lincoln | Nebraska | 68506 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| The Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| The Stern Cardiovascular Center | Germantown | Tennessee | 38138 | United States |
| Tennessee Cardiovascular Research Institute | Nashville | Tennessee | 37205 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Inova Heart & Vascular Institute/ Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| McGill University Hospital Centre | Montreal | Quebec | H3A 1A1 | Canada |
| Keteyian SJ, Brawner CA, Ehrman JK, Ivanhoe R, Boehmer JP, Abraham WT; PEERLESS-HF Trial Investigators. Reproducibility of peak oxygen uptake and other cardiopulmonary exercise parameters: implications for clinical trials and clinical practice. Chest. 2010 Oct;138(4):950-5. doi: 10.1378/chest.09-2624. Epub 2010 Jun 3. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | HeartNet and Optimal Medical/Device Therapy |
| BG001 | Control | Optimal Medical/Device Therapy alone |
| 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 Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Self-reported race. Since the participants were allowed to select more than one race, the sum of races is greater than the number of participants in each group. | Number | participants |
| |||||||||||||||
| New York Heart Association (NYHA) Classification | Number | participants |
| ||||||||||||||||
| Heart Failure Etiology | Number | participants |
| ||||||||||||||||
| Duration of Heart Failure (time) | Mean | Standard Deviation | years |
| |||||||||||||||
| Cardiac Medications | Baseline information for specific cardiac medications was requested. Since most participants were on more than one medication, the sum of medications are greater than the number of participants in each group. | Number | participants |
| |||||||||||||||
| Medical History and Co-Morbidities | Baseline information on specific co-morbities was requested. Since many participants had more than one co-morbidity, the sum of co-morbidities are greater than the number of participants in each group. | 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 | Responder Analysis - Peak Oxygen Uptake (Peak VO2) | A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline. | The population is intent to treat. | Posted | Apr 2011 | Number | participants | Baseline to 6 months |
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| Primary | Responder Analysis - Six (6) Minute Walk (6MW) Distance | A participant was considered a "responder" if 6MW distance at 6 months was at least 45 meters more than at baseline. | The population is intent to treat. | Posted | Apr 2011 | Number | participants | Baseline to 6 months |
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| Primary | Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score. | The population is intent to treat. | Posted | Number | participants | baseline to 6 months |
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| Primary | Number of Participant Deaths | Total number of participants who died within 12 months of enrollment into the trial. | The population is intent to treat. | Posted | Number | participants | 12 months |
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| Secondary | Change in New York Heart Association (NYHA) Functional Class | Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remained the same as baseline. "Improved" means the participant's functional class improved (became lower in number) by at least one class. "Worsened" means the participant's functional class deteriorated (became higher in number) by at least one class. | Population is intent to treat. | Posted | Apr 2011 | Number | participants | baseline to 6 months |
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| Secondary | Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented. | Population is intent to treat | Posted | Apr 2011 | Mean | Standard Deviation | score on a scale | baseline to 6 months |
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| Secondary | Change in Left Ventricular Mass | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure. | Population is intent to treat. | Posted | Apr 2011 | Median | Full Range | grams | baseline to 6 months |
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| Secondary | Responder Analysis - Peak Oxygen Uptake (Peak VO2) | A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline. | Population is intent to treat. | Posted | Apr 2011 | Number | participants | baseline to 12 months |
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| Secondary | Responder Analysis - Six (6) Minute Walk (6MW) Distance | A participant was considered a "responder" if 6MW distance at 12 months was at least 45 meters more than at baseline. | Population is intent to treat | Posted | Number | participants | baseline to 12 Months |
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| Secondary | Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score | A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score. | Population is intent to treat. | Posted | Apr 2011 | Number | participants | baseline to 12 months |
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| Secondary | Heart Failure Hospitalization - Actuarial Analysis | Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment | Population is intent to treat. | Posted | Apr 2011 | Number | participants | 12 months |
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| Secondary | Change in Left Ventricular End Diastolic Volume | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure. | Population is intent to treat. | Posted | Apr 2011 | Median | Full Range | milliliters | baseline to 6 months |
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| Secondary | Change in Left Ventricular End Systolic Volume | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure. | Population is intent to treat. | Posted | Apr 2011 | Median | Full Range | milliliters | baseline to 6 months |
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| Secondary | Change in Ejection Fraction | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented. | Population is intent to treat. | Posted | Apr 2011 | Median | Full Range | percent | baseline to 6 months |
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| Secondary | Change in Left Ventricular End Diastolic Diameter | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure. | Population is intent to treat. | Posted | Apr 2011 | Median | Full Range | centimeters | baseline to 6 months |
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| Secondary | Change in Left Ventricular End Systolic Diameter | The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure. | Population is intent to treat. | Posted | Apr 2011 | Median | Full Range | centimeters | baseline to 6 months |
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| Secondary | Technical Success (Number of Treatment Arm Participants Successfully Implanted) | "Technical success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis. | Population is as treated, treatment only. | Posted | Apr 2011 | Number | participants | 1 day |
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| Secondary | Heart Failure Death | Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure | Population is intent to treat. | Posted | Apr 2011 | Number | participants | 12 months |
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| Secondary | Heart Failure Death - Actuarial Analysis | Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure | Population is intent to treat. | Posted | Apr 2011 | Number | participants | 12 months |
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| Secondary | Heart Failure Hospitalization | Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment. | Population is intent to treat. | Posted | Apr 2011 | Number | participants | 12 months |
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| Secondary | All-Cause Hospitalization | Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis. | Population is intent to treat. | Posted | Apr 2011 | Number | participants | 12 months |
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| Secondary | All-Cause Hospitalization - Actuarial Analysis | Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations | Population is intent to treat. | Posted | Apr 2011 | Number | participants | 12 months |
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| Secondary | Participants Experiencing Serious Adverse Events | Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment | Population is intent to treat. | Posted | Apr 2011 | Number | participants | 12 months |
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| Secondary | Serious Adverse Events - Actuarial Analysis | Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events | Population is intent to treat. | Posted | Apr 2011 | Number | participants | 12 months |
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| Secondary | Days Alive Out of Hospital | Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis. | Population is intent to treat. | Posted | Apr 2011 | Median | Full Range | days | 12 months |
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Participants were followed up to 3.5 years
Events adjudicated per Clinical Events Committee (CEC) Charter by independent CEC.
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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 | Treatment | HeartNet and Optimal Medical/Device Therapy | 57 | 96 | 85 | 96 | ||
| EG001 | Control | Optimal Medical/Device Therapy alone | 47 | 114 | 71 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening Heart Failure | Cardiac disorders | Systematic Assessment | Non-perioperative |
| |
| Non-Ischemic Atrial/Ventricular Dysrhythmia | Cardiac disorders | Systematic Assessment | Non-perioperative |
| |
| Cardiac Procedure | Cardiac disorders | Systematic Assessment | Non-perioperative |
| |
| Other Cardiac Hospitalization | Cardiac disorders | Systematic Assessment | Non-perioperative |
| |
| Syncope | Cardiac disorders | Systematic Assessment | Non-perioperative |
| |
| Myocardial Infarct | Cardiac disorders | Systematic Assessment | Non-perioperative |
| |
| Coronary Insufficiency/Acute Coronary Syndrome/Unstable Angina | Cardiac disorders | Systematic Assessment | Non-perioperative |
| |
| Peripheral Vascular Disease | Vascular disorders | Systematic Assessment | Non-perioperative |
| |
| Pulmonary or Vascular Emboli | Vascular disorders | Systematic Assessment | Non-perioperative |
| |
| Stroke | Vascular disorders | Systematic Assessment | Non-perioperative |
| |
| Transient Ischemic Attack | Vascular disorders | Systematic Assessment | Non-perioperative |
| |
| Non-cardiac vascular surgery | Vascular disorders | Systematic Assessment | Non-perioperative |
| |
| Other Vascular Condition (nonspecific) | Vascular disorders | Systematic Assessment | Non-perioperative |
| |
| Non-cardiac/Non-vascular | General disorders | Systematic Assessment | Non-perioperative |
| |
| Arrythmias | Cardiac disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Pericardial Syndrome | Cardiac disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Hypotension | Cardiac disorders | Systematic Assessment | Perioperative, treatment only |
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| Blood Loss | Cardiac disorders | Systematic Assessment | Perioperative, treatment only |
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| Worsening Heart Failure | Cardiac disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Myocardial Infarction | Cardiac disorders | Systematic Assessment | Perioperative, treatment only |
| |
| LV Laceration | Cardiac disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Chest Pain Syndrome | Cardiac disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Stroke | Nervous system disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Renal Failure/Insufficiency | Renal and urinary disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Prolonged Ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Sleep Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Bacteremia/Sepsis | Infections and infestations | Systematic Assessment | Perioperative, treatment only |
| |
| Pneumonia | Infections and infestations | Systematic Assessment | Perioperative, treatment only |
| |
| Dehydration | General disorders | Systematic Assessment | Perioperative, treatment only |
| |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Perioperative, treatment only |
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| Gastroesophageal Reflux | Gastrointestinal disorders | Systematic Assessment | Perioperative, treatment only |
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| Gastrointestinal Bleeding | Gastrointestinal disorders | Systematic Assessment | Perioperative, treatment only |
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| Neuropathy | Nervous system disorders | Systematic Assessment | Perioperative, treatment only |
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| Laryngeal Granuloma | General disorders | Systematic Assessment | Perioperative, treatment only |
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| Ileus | General disorders | Systematic Assessment | Perioperative, treatment only |
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| Alcohol Withdrawal | General disorders | Systematic Assessment | Perioperative, treatment only |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Perioperative, treatment only |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
| ||
| Respiratory/Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neurology | Nervous system disorders | Systematic Assessment |
| ||
| Renal | Renal and urinary disorders | Systematic Assessment |
| ||
| Hematology | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Genital-urinary | Renal and urinary disorders | Systematic Assessment |
| ||
| General | General disorders | Systematic Assessment |
|
An interim analysis indicated trial futility based on a primary endpoint. Enrollment was suspended in July, 2009. Study was terminated as of April, 2011 due to insufficient resources.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kolber, General Manager, VP of Regulatory Affairs | Paracor Medical, Inc. | 408-734-6000 | info@paracor.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| NYHA II; Pts w/cardiac disease, slight limits |
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| NYHA III; Marked limit to physical activity |
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| NYHA IV; inability to have activity w/o discomfort |
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| Ischemic |
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| Unknown |
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| Antiogensin Receptor Blockers |
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| Beta Blockers |
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| Diuretics (other than Spironolactone) |
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| Aldosterone Inhibitors |
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| Digoxin |
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| Pulmonary Hypertension |
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| Diabetes Mellitus |
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| Chronic Obstructive Pulmonary Disease (COPD) |
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| Sleep Apnea |
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| Asthma |
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| Coronary Artery Disease with Angioplasty/Stent |
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| Stroke TIA/Other Thromboembolic Events |
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| Peripheral Vascular Disease |
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| Myocardial Infarction |
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| Ventricular Tachycardia |
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| Atrial Fibrillation |
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| Biventricular Pacemaker |
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| Biventricular ICD |
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| Pacemaker alone |
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| ICD alone |
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| ICD with Bradycardia Pacing Capability |
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