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Resources unavailable to continue study follow-up.
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This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles.
No formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. The results of the study will be used to guide the design and sample size estimation of future studies.
Please refer to brief summary.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of the PVSS Implant | Device | Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death or Additional Surgical Session at 6 Months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Success (Number of Participants Successfully Implanted) | "Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. | 1 day |
| Change in NYHA Functional Class |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William T Abraham, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, Division of Cardiovascular Disease | Birmingham | Alabama | 35294 | United States | ||
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12 investigational sites enrolled 39 subjects between January 2005 and October 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-randomized, Single- Arm, Treatment | Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remains the same as baseline. "Improved" means the participant's functional class has improved (become lower in number) by at least one class. "Worsened" means the participatn's functional class has deteriorated (become higher in number) by at least one class. |
| Baseline to 6 months |
| Changes in Left Ventricular Diameters | Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements) | Baseline to 6 months |
| Changes in Left Ventricular Volumes | Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements) | Baseline to 6 months |
| Change in Left Ventricular Ejection Fraction | Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements) | Baseline to 6 months |
| Change in Left Ventricular Mass | Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements) | Baseline to 6 months |
| Changes in 6 Minute Walk | Mean change in 6 minute walk distance (meters) between baseline and 6 months | Baseline to 6 months |
| Changes in Cardiopulmonary Tests | Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months | Baseline to 6 months |
| Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score | The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death. | Baseline to 6 months |
| Number of Adverse Events | Total adverse events reported prior to study closure | Study duration |
| Number of Participants Who Died | Total number of patient deaths reported prior to study closure | Study duration |
| University of Colorado, Health Sciences Center |
| Denver |
| Colorado |
| 80262 |
| United States |
| University of Florida, Division of Cardiology | Gainesville | Florida | 32610 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 | United States |
| Mid America Heart Institute | Kansas City | Missouri | 64111 | United States |
| BryanLGH Heart Institute | Lincoln | Nebraska | 68506 | United States |
| The Ohio State University Heart Center | Columbus | Ohio | 43210 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-randomized, Single- Arm, Treatment | Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Measured as Caucasian, Black, of African heritage, and Hispanic | Count of Participants | Participants |
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| Etiology | Number | participants |
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| Duration of heart failure | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Death or Additional Surgical Session at 6 Months | Per protocol | Posted | Apr 2011 | Number | participants | 6 months |
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| Secondary | Implant Success (Number of Participants Successfully Implanted) | "Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. | per protocol | Posted | Number | participants | 1 day |
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| Secondary | Change in NYHA Functional Class | Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remains the same as baseline. "Improved" means the participant's functional class has improved (become lower in number) by at least one class. "Worsened" means the participatn's functional class has deteriorated (become higher in number) by at least one class. | per protocol | Posted | Apr 2011 | Number | participants | Baseline to 6 months |
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| Secondary | Changes in Left Ventricular Diameters | Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements) | per protocol | Posted | Apr 2011 | Mean | Standard Deviation | centimeters | Baseline to 6 months |
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| Secondary | Changes in Left Ventricular Volumes | Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements) | per protocol | Posted | Mean | Standard Deviation | milliliters | Baseline to 6 months |
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| Secondary | Change in Left Ventricular Ejection Fraction | Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements) | per protocol | Posted | Mean | Standard Deviation | Percentage | Baseline to 6 months |
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| Secondary | Change in Left Ventricular Mass | Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements) | Posted | Mean | Standard Deviation | grams | Baseline to 6 months |
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| Secondary | Changes in 6 Minute Walk | Mean change in 6 minute walk distance (meters) between baseline and 6 months | per protocol | Posted | Apr 2011 | Mean | Standard Deviation | meters | Baseline to 6 months |
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| Secondary | Changes in Cardiopulmonary Tests | Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months | per protocol | Posted | Mean | Standard Deviation | ml/kg/min | Baseline to 6 months |
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| Secondary | Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score | The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death. | per protocol | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
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| Secondary | Number of Adverse Events | Total adverse events reported prior to study closure | per protocol | Posted | Number | events | Study duration |
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| Secondary | Number of Participants Who Died | Total number of patient deaths reported prior to study closure | per protocol | Posted | Number | participants | Study duration |
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6 years, 3 months (maximum)
Patients followed from enrollment until study termination, death, or withdrawal
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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 | Non-randomized, Single- Arm, Treatment | Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach. | 30 | 39 | 39 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General | General disorders | Systematic Assessment |
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| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Genital-urinary | Renal and urinary disorders | Systematic Assessment |
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| Hematology | Blood and lymphatic system disorders | Systematic Assessment |
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| Neurology | Nervous system disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General | General disorders | Systematic Assessment |
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| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Genital-urinary | Renal and urinary disorders | Systematic Assessment |
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| Hematology | Blood and lymphatic system disorders | Systematic Assessment |
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| Neurology | Nervous system disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal | Renal and urinary disorders | Systematic Assessment |
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Insufficient resources to continue study follow-up.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kolber, General Manager, VP, Regulatory Affairs | Paracor Medical, Inc. | 408-734-6000 | info@paracor.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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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| Denominators |
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| Categories |
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| LVEDV (ml) |
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| LVESV (ml) |
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|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
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| Adverse Events |
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| Serious Adverse Events |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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