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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREATMENT Group | Active Comparator | Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System |
|
| CONTROL Group | Placebo Comparator | Standard of care HF management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HF Pressure Measurement System | Device | A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Heart Failure Related (HFR) Hospitalizations | 6 months | |
| Freedom From a Device/System-related Complication (DSRC). | A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:
| 6 months |
| Freedom From Pressure Sensor Failure | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Artery Mean Pressure | 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 | Description | Time Frame |
|---|---|---|
| Rate of HFR Hospitalizations | Study duration: average patient follow-up of 15 months | |
| Freedom From a Device/System-related Complication (DSRC) | Study duration: average patient follow-up of 15 months | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Adamson, MD, FACC | Oklahoma Heart Hospital | Principal Investigator |
| William T Abraham, MD, FACC | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CardioMEMS Investigational Sites | Nationwide | Georgia | 30313 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40223608 | Derived | 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. | |
| 33626889 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System |
| FG001 | Control | CONTROL group: standard of care HF management |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Months |
| |||||||||||||
| Study Duration: 15 Months Avg. Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Rate of Heart Failure Related (HFR) Hospitalizations | Posted | Number | HFR hospitalizations/patient/6 months | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| respiratory | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Bauman | CardioMEMS, Inc. | 4043458235 | jbauman@cardiomems.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months |
| Proportion of Patients Hospitalized for Heart Failure | 6 months |
| Days Alive Outside of the Hospital | 6 months |
| Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ) | 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. | 6 months |
| Freedom From Pressure Sensor Failure |
| Study duration: average patient follow-up of 15 months |
| 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. |
| 28982501 | Derived | 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. |
| 27220593 | Derived | 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. |
| 26560249 | Derived | 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. |
| 25813770 | Derived | 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. |
| 25286913 | Derived | 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. |
| 21315441 | Derived | 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. |
| NOT COMPLETED |
|
CONTROL group: standard of care HF management
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Freedom From a Device/System-related Complication (DSRC). | A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:
| 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. | Posted | Number | cases | 6 months | Implantation Cases | Participants |
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| Primary | Freedom From Pressure Sensor Failure | 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. | 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). | Posted | Number | participants | 6 months |
|
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| Secondary | Change From Baseline in Pulmonary Artery Mean Pressure | 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. | Posted | Mean | Standard Deviation | mmHg * days | 6 months |
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| Secondary | Proportion of Patients Hospitalized for Heart Failure | Posted | Number | participants | 6 months |
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| Secondary | Days Alive Outside of the Hospital | Posted | Mean | Standard Deviation | days | 6 months |
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| Secondary | Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ) | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Other Pre-specified | Rate of HFR Hospitalizations | Posted | Number | HFR hospitalizations/patient-year | Study duration: average patient follow-up of 15 months |
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| Other Pre-specified | Freedom From a Device/System-related Complication (DSRC) | Posted | Number | participants | Study duration: average patient follow-up of 15 months |
|
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| Other Pre-specified | Freedom From Pressure Sensor Failure | Posted | Number | participants | Study duration: average patient follow-up of 15 months |
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| 121 |
| 270 |
| 175 |
| 270 |
| EG001 | Control | CONTROL group: standard of care HF management | 155 | 280 | 174 | 280 |
| Respiratory | Respiratory, thoracic and mediastinal disorders |
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| infections | Infections and infestations |
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| vascular | Vascular disorders |
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| renal and urinary | Renal and urinary disorders |
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| metabolism and nutrition | Metabolism and nutrition disorders |
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| nervous system | Nervous system disorders |
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| gastrointestinal | Gastrointestinal disorders |
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| general disorders | General disorders |
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| surgical | Surgical and medical procedures |
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| cardiac | Cardiac disorders |
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| infections | Infections and infestations |
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| gastrointestinal | Gastrointestinal disorders |
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| metabolism and nutrition | Metabolism and nutrition disorders |
|
| nervous system | Nervous system disorders |
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| general disorders | General disorders |
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| musculoskeletal | Musculoskeletal and connective tissue disorders |
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| renal and urinary | Renal and urinary disorders |
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| vascular | Vascular disorders |
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| investigations | Investigations |
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| blood and lymphatic system | Blood and lymphatic system disorders |
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| psychiatric | Psychiatric disorders |
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| skin and subcutaneous tissue | Skin and subcutaneous tissue disorders |
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| injury | Injury, poisoning and procedural complications |
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