Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT00291551
Status:
TERMINATED
Last Update Posted:
2012-05-21
First Post:
2006-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Paracor Ventricular Support System (PVSS) for Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@paracor.com', 'phone': '408-734-6000', 'title': 'Michael Kolber, General Manager, VP, Regulatory Affairs', 'organization': 'Paracor Medical, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Insufficient resources to continue study follow-up.'}}, 'adverseEventsModule': {'timeFrame': '6 years, 3 months (maximum)', 'description': 'Patients followed from enrollment until study termination, death, or withdrawal', 'eventGroups': [{'id': 'EG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.', 'otherNumAtRisk': 39, 'otherNumAffected': 39, 'seriousNumAtRisk': 39, 'seriousNumAffected': 30}], 'otherEvents': [{'term': 'General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 118, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 66, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genital-urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 37, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'General', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 28, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 84, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genital-urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Death or Additional Surgical Session at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single Arm, Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Implant Success (Number of Participants Successfully Implanted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': '"Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Change in NYHA Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Maintained', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 6 months', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Changes in Left Ventricular Diameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'classes': [{'title': 'LVEDD (cm)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'LVESD (cm)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Changes in Left Ventricular Volumes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single Arm, Treatment'}], 'classes': [{'title': 'LVEDV (ml)', 'categories': [{'measurements': [{'value': '-31.6', 'spread': '65.2', 'groupId': 'OG000'}]}]}, {'title': 'LVESV (ml)', 'categories': [{'measurements': [{'value': '-29.6', 'spread': '61.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single Arm, Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '6.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single Arm, Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.6', 'spread': '55.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in 6 Minute Walk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'spread': '122.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in 6 minute walk distance (meters) between baseline and 6 months', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol', 'anticipatedPostingDate': '2011-04'}, {'type': 'SECONDARY', 'title': 'Changes in Cardiopulmonary Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months', 'unitOfMeasure': 'ml/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.8', 'spread': '22.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study duration', 'description': 'Total adverse events reported prior to study closure', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study duration', 'description': 'Total number of patient deaths reported prior to study closure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '12 investigational sites enrolled 39 subjects between January 2005 and October 2006.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-randomized, Single- Arm, Treatment', 'description': '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.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '11.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measured as Caucasian, Black, of African heritage, and Hispanic', 'unitOfMeasure': 'Participants'}, {'title': 'Etiology', 'classes': [{'title': 'Ischemic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Non-ischemic', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of heart failure', 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '4.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Resources unavailable to continue study follow-up.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-14', 'studyFirstSubmitDate': '2006-02-10', 'resultsFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2006-02-10', 'lastUpdatePostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-10', 'studyFirstPostDateStruct': {'date': '2006-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death or Additional Surgical Session at 6 Months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Implant Success (Number of Participants Successfully Implanted)', 'timeFrame': '1 day', 'description': '"Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.'}, {'measure': 'Change in NYHA Functional Class', 'timeFrame': 'Baseline to 6 months', 'description': '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.'}, {'measure': 'Changes in Left Ventricular Diameters', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)'}, {'measure': 'Changes in Left Ventricular Volumes', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)'}, {'measure': 'Change in Left Ventricular Ejection Fraction', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)'}, {'measure': 'Change in Left Ventricular Mass', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)'}, {'measure': 'Changes in 6 Minute Walk', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in 6 minute walk distance (meters) between baseline and 6 months'}, {'measure': 'Changes in Cardiopulmonary Tests', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months'}, {'measure': 'Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score', 'timeFrame': 'Baseline to 6 months', 'description': "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."}, {'measure': 'Number of Adverse Events', 'timeFrame': 'Study duration', 'description': 'Total adverse events reported prior to study closure'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Study duration', 'description': 'Total number of patient deaths reported prior to study closure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure, Congestive']}, 'descriptionModule': {'briefSummary': '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.\n\nNo 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.', 'detailedDescription': 'Please refer to brief summary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NYHA functional class II or III\n* Best medical therapy\n* Ejection fraction \\<= 35%\n\nExclusion Criteria:\n\n* Heart measurements too large or small for implant sizes\n* Intra-cardiac thrombus\n* Restrictive cardiomyopathy\n* Not a candidate for sternotomy\n* Expected adhesions\n* Previous coronary artery bypass graft (CABG)\n* Active infection\n* Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months\n* Myocardial infarction (MI) within 1 month'}, 'identificationModule': {'nctId': 'NCT00291551', 'acronym': 'PEERLESS-HF', 'briefTitle': 'Paracor Ventricular Support System (PVSS) for Patients With Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Paracor Medical, Inc'}, 'officialTitle': 'Paracor Ventricular Support System: United States Clinical Investigational Plan', 'orgStudyIdInfo': {'id': '102.1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Placement of the PVSS Implant', 'type': 'DEVICE', 'otherNames': ['HeartNet', 'Ventricular support device', 'Ventricular elastic support therapy'], 'description': 'Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham, Division of Cardiovascular Disease', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado, Health Sciences Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Division of Cardiology', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mid America Heart Institute', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'BryanLGH Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Heart Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'William T Abraham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paracor Medical, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}