Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-25 @ 2:19 AM
Study NCT ID:
NCT00531661
Status:
COMPLETED
Last Update Posted:
2015-01-28
First Post:
2007-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
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': 'jbauman@cardiomems.com', 'phone': '4043458235', 'title': 'Jordan Bauman', 'organization': 'CardioMEMS, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System', 'otherNumAtRisk': 270, 'otherNumAffected': 175, 'seriousNumAtRisk': 270, 'seriousNumAffected': 121}, {'id': 'EG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management', 'otherNumAtRisk': 280, 'otherNumAffected': 174, 'seriousNumAtRisk': 280, 'seriousNumAffected': 155}], 'otherEvents': [{'term': 'respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 51, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 62, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 73, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 58, 'numAffected': 38}], 'organSystem': 'Cardiac disorders'}, {'term': 'infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 50, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 56, 'numAffected': 46}], 'organSystem': 'Infections and infestations'}, {'term': 'gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 61, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 49, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'metabolism and nutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 57, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 47, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 32, 'numAffected': 24}], 'organSystem': 'Nervous system disorders'}, {'term': 'general disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 44, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'General disorders'}, {'term': 'musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 34, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'renal and urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 33, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Vascular disorders'}, {'term': 'investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Investigations'}, {'term': 'blood and lymphatic system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders'}, {'term': 'skin and subcutaneous tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'seriousEvents': [{'term': 'Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 144, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 187, 'numAffected': 101}], 'organSystem': 'Cardiac disorders'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Infections and infestations'}, {'term': 'vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Vascular disorders'}, {'term': 'renal and urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'metabolism and nutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Nervous system disorders'}, {'term': 'gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'general disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'General disorders'}, {'term': 'surgical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 280, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Surgical and medical procedures'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Heart Failure Related (HFR) Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System'}, {'id': 'OG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000'}, {'value': '0.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'HFR hospitalizations/patient/6 months', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Freedom From a Device/System-related Complication (DSRC).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}]}, {'units': 'Implantation Cases', 'counts': [{'value': '575', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '567', 'groupId': 'OG000', 'lowerLimit': '97.3%', 'upperLimit': '99.4%'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implantation cases was at least 80%. The statistical hypotheses were:\n\nNull: (Freedom from device / system-related complications) ≤ 80%\n\nAlternative: (Freedom from device / system-related complications) \\> 80%', 'statisticalMethod': 'exact test of binomial proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value from exact test of binomial proportions compared proportion of all implantation cases free from DSRC to OPC of 0.80.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:\n\n* is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)\n* results in the death of the subject\n* results in the explant of the device', 'unitOfMeasure': 'cases', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implantation Cases', 'denomUnitsSelected': 'Participants', 'populationDescription': 'This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device as well as patients where an implant was attempted. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC). This population includes 550 implanted patients + 25 patient attempts.'}, {'type': 'PRIMARY', 'title': 'Freedom From Pressure Sensor Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Randomized Study Cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '550', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all patients implanted was at least 90%. The statistical hypotheses were:\n\nNull: (Freedom from device / system-related complications) ≤ 90%\n\nAlternative: (Freedom from device / system-related complications) \\> 90%', 'statisticalMethod': 'exact test of binomial proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Artery Mean Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System'}, {'id': 'OG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management'}], 'classes': [{'categories': [{'measurements': [{'value': '-155.7', 'spread': '1088.0', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '951.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0077', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.', 'unitOfMeasure': 'mmHg * days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Hospitalized for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System'}, {'id': 'OG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0292', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days Alive Outside of the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System'}, {'id': 'OG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management'}], 'classes': [{'categories': [{'measurements': [{'value': '174.4', 'spread': '31.1', 'groupId': 'OG000'}, {'value': '172.1', 'spread': '37.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0280', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System'}, {'id': 'OG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management'}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '24.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0236', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of HFR Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System'}, {'id': 'OG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000'}, {'value': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Study duration: average patient follow-up of 15 months', 'unitOfMeasure': 'HFR hospitalizations/patient-year', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Freedom From a Device/System-related Complication (DSRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '498', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Duration Study Cohort', 'description': 'Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.'}], 'classes': [{'categories': [{'measurements': [{'value': '498', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implanted patients was at least 80%. The statistical hypotheses were:\n\nNull: (Freedom from device / system-related complications) ≤ 80%\n\nAlternative: (Freedom from device / system-related complications) \\> 80%', 'statisticalMethod': 'exact test of binomial proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value from exact test of binomial proportions compared proportion of all implanted patients free from DSRC to OPC of 0.80.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Study duration: average patient follow-up of 15 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Freedom From Pressure Sensor Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '498', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Duration Study Cohort', 'description': 'Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.'}], 'classes': [{'categories': [{'measurements': [{'value': '498', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all implanted patients was at least 90%. The statistical hypotheses were:\n\nNull: (Freedom from device / system-related complications) ≤ 90%\n\nAlternative: (Freedom from device / system-related complications) \\> 90%', 'statisticalMethod': 'exact test of binomial proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Study duration: average patient follow-up of 15 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System'}, {'id': 'FG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management'}], 'periods': [{'title': '6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '280'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}]}, {'title': 'Study Duration: 15 Months Avg. Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '197'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '57'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System'}, {'id': 'BG001', 'title': 'Control', 'description': 'CONTROL group: standard of care HF management'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-16', 'studyFirstSubmitDate': '2007-09-18', 'resultsFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2007-09-18', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-28', 'studyFirstPostDateStruct': {'date': '2007-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of HFR Hospitalizations', 'timeFrame': 'Study duration: average patient follow-up of 15 months'}, {'measure': 'Freedom From a Device/System-related Complication (DSRC)', 'timeFrame': 'Study duration: average patient follow-up of 15 months'}, {'measure': 'Freedom From Pressure Sensor Failure', 'timeFrame': 'Study duration: average patient follow-up of 15 months'}], 'primaryOutcomes': [{'measure': 'Rate of Heart Failure Related (HFR) Hospitalizations', 'timeFrame': '6 months'}, {'measure': 'Freedom From a Device/System-related Complication (DSRC).', 'timeFrame': '6 months', 'description': 'A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:\n\n* is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)\n* results in the death of the subject\n* results in the explant of the device'}, {'measure': 'Freedom From Pressure Sensor Failure', 'timeFrame': '6 months', 'description': 'A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Pulmonary Artery Mean Pressure', 'timeFrame': '6 months', 'description': 'Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.'}, {'measure': 'Proportion of Patients Hospitalized for Heart Failure', 'timeFrame': '6 months'}, {'measure': 'Days Alive Outside of the Hospital', 'timeFrame': '6 months'}, {'measure': 'Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)', 'timeFrame': '6 months', 'description': "THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '40223608', 'type': 'DERIVED', 'citation': 'Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.'}, {'pmid': '33626889', 'type': 'DERIVED', 'citation': 'Varma N, Bourge RC, Stevenson LW, Costanzo MR, Shavelle D, Adamson PB, Ginn G, Henderson J, Abraham WT; CHAMPION Investigator Group. Remote Hemodynamic-Guided Therapy of Patients With Recurrent Heart Failure Following Cardiac Resynchronization Therapy. J Am Heart Assoc. 2021 Feb;10(5):e017619. doi: 10.1161/JAHA.120.017619. Epub 2021 Feb 25.'}, {'pmid': '28982501', 'type': 'DERIVED', 'citation': 'Givertz MM, Stevenson LW, Costanzo MR, Bourge RC, Bauman JG, Ginn G, Abraham WT; CHAMPION Trial Investigators. Pulmonary Artery Pressure-Guided Management of Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2017 Oct 10;70(15):1875-1886. doi: 10.1016/j.jacc.2017.08.010.'}, {'pmid': '27220593', 'type': 'DERIVED', 'citation': 'Adamson PB, Abraham WT, Stevenson LW, Desai AS, Lindenfeld J, Bourge RC, Bauman J. Pulmonary Artery Pressure-Guided Heart Failure Management Reduces 30-Day Readmissions. Circ Heart Fail. 2016 Jun;9(6):e002600. doi: 10.1161/CIRCHEARTFAILURE.115.002600.'}, {'pmid': '26560249', 'type': 'DERIVED', 'citation': 'Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB; CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.'}, {'pmid': '25813770', 'type': 'DERIVED', 'citation': 'Raina A, Abraham WT, Adamson PB, Bauman J, Benza RL. Limitations of right heart catheterization in the diagnosis and risk stratification of patients with pulmonary hypertension related to left heart disease: insights from a wireless pulmonary artery pressure monitoring system. J Heart Lung Transplant. 2015 Mar;34(3):438-47. doi: 10.1016/j.healun.2015.01.983. Epub 2015 Feb 7.'}, {'pmid': '25286913', 'type': 'DERIVED', 'citation': 'Adamson PB, Abraham WT, Bourge RC, Costanzo MR, Hasan A, Yadav C, Henderson J, Cowart P, Stevenson LW. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circ Heart Fail. 2014 Nov;7(6):935-44. doi: 10.1161/CIRCHEARTFAILURE.113.001229. Epub 2014 Oct 6.'}, {'pmid': '21315441', 'type': 'DERIVED', 'citation': 'Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF\n2. Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)\n3. Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.\n4. At least 1 HF hospitalization within 12 months of Screening Visit\n5. Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)\n\nExclusion Criteria:\n\n1. Subjects with history of recurrent (\\> 1) pulmonary embolism or deep vein thrombosis\n2. Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization\n3. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit\n4. Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment\n5. Subjects with a Glomerular Filtration Rate (GFR) \\<25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis\n6. Subjects likely to undergo heart transplantation within 6 months of Screening Visit\n7. Subjects with congenital heart disease or mechanical right heart valve(s)\n8. Subjects with known coagulation disorders\n9. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel"}, 'identificationModule': {'nctId': 'NCT00531661', 'acronym': 'CHAMPION', 'briefTitle': 'CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardioMEMS'}, 'officialTitle': 'CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients', 'orgStudyIdInfo': {'id': 'CM-06-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TREATMENT Group', 'description': 'Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System', 'interventionNames': ['Device: HF Pressure Measurement System']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CONTROL Group', 'description': 'Standard of care HF management'}], 'interventions': [{'name': 'HF Pressure Measurement System', 'type': 'DEVICE', 'description': 'A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.', 'armGroupLabels': ['TREATMENT Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30313', 'city': 'Nationwide', 'state': 'Georgia', 'country': 'United States', 'facility': 'CardioMEMS Investigational Sites'}], 'overallOfficials': [{'name': 'Phillip Adamson, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma Heart Hospital'}, {'name': 'William T Abraham, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardioMEMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}