Heart FailureNCT05080504
Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)
An observational study of Heart Failure, run by Eko Devices, Inc. at 2 sites in United States.
Trial summary
This study will enroll heart failure (HF) patients who are under active management with an implanted pulmonary artery pressure sensor (CardioMEMS). Subjects will be provided an electronic stethoscope (the Eko DUO) to take at-home heart sound, lung sound, and ECG recordings in conjunction with regimented CardioMEMS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Eko DUO
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be identified via the medical center's registry of patients who are actively managed with CardioMEMS. Alternatively, the center's schedule of CardioMEMS implantations will be monitored for potential subjects with newly implanted CardioMEMS.
Who may be able to join
- Aged 18 years and older
- Patient or healthcare proxy willing to give written informed consent to participate
- Presence of an implanted CardioMEMS device or imminent implantation of a CardioMEMS device
- Expressed willingness to take DUO recordings immediately before or after taking their CardioMEMS measurements, on the same schedule prescribed by their physician
- Functioning iOS or Android smartphone or tablet that can download and run the companion Eko application
- Access to WiFi or cellular data connection at home
Who cannot join
- Patient or healthcare proxy is unwilling or unable to give written informed consent
- Patient is enrolled in another study that may interfere with the observations from this study
- Acute pericarditis
- Healing chest wall wounds (e.g., sternotomy or thoracotomy)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Irving Medical Center
New York, New York, 10032
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 22191
About this study
This study will enroll heart failure (HF) patients who are under active management with an implanted pulmonary artery pressure sensor (CardioMEMS). Subjects will be provided an electronic stethoscope (the Eko DUO) to take at-home heart sound, lung sound, and ECG recordings in conjunction with regimented CardioMEMS measurements. These two datasets will be used to confirm whether an AI/ML model to track HF status can be developed.
Read the detailed description
Heart failure (HF) affects an estimated 6.2 million Americans over the age of 20 and carries a very high healthcare system burden worldwide. Annual costs for HF management in the United States were estimated at $30.7 billion in 2012 and are projected to increase to $68.7 billion by 2030. The primary cost driver for HF management is a high rate of acute decompensation and subsequent hospitalization. The mean per-patient cost of an HF-related hospitalization is estimated to be $14,631.
Among the conditions that the Centers of Medicare and Medicaid Services (CMS) monitors for their Hospital Readmission Reduction Program, HF has the highest median readmission rate at days 1-29 (23%) and days 1-60 (11.4%) postdischarge. The cost burden of HF readmission is $2.7 billion in 2013. A meta-analysis from 2012 estimated that 23.1% of HF readmissions are avoidable, although individual studies ranged from 5% to 79%. Many health plans, including CMS, have focused on interventions that monitor patients for early detection of HF decompensation. Earlier interventions can help care teams prevent avoidable hospitalizations.
Invasive hemodynamic sensor devices have enabled HF care teams to better predict and prevent HF decompensation events, and thus prevent rehospitalizations. One such device is the CardioMEMS pulmonary artery (PA) sensor (Abbott Inc., Atlanta, GA, USA). The CardioMEMS is implanted in a branch of the left PA, allowing for daily measurements of PA pressures. PA pressures are used as a surrogate marker of filling pressure, and rising filling pressures, in turn, are a marker that precedes the exacerbation of HF. The CHAMPIONS trial demonstrated that remote diuretic management using CardioMEMS reduced HF all-cause hospitalizations by 43% and mortality by 57%. Unfortunately, CardioMEMS as an HF solution is invasive, costly (average sales price of $17,750), indicated for a restricted patient population (NYHA class III HF who have been hospitalized within the last year), and has limited reimbursement coverage due to equivocal cost-effectiveness projections.
This has stimulated a search for less expensive, non-invasive sensors that may correlate with fluid status in HF patients. A study in Taiwan demonstrated that outpatient therapy guided by an inpatient device with ECG and sound sensors reduced post-discharge HF utilization by 31% when compared to a control group using symptoms to guide therapy. The LINK-HF study demonstrated that a wearable patch with ECG and sound sensors could predict HF readmissions with a sensitivity of 76% to 88%, a specificity of 85%, and a median lead time of 6.5 days.
Despite these initially promising results, however, these devices have significant disadvantages. The inpatient device used in the Taiwanese study could not be adapted into a portable form factor for outpatient use. Wearable devices can be rigid, uncomfortable, and highly visible, all of which can interfere with patient function and decrease monitoring compliance.
Therefore, there remains an unmet clinical need for a widely available, non-invasive, affordable medical device that can estimate an HF patient's hemodynamic fluid status and inform the HF care management team. The ultimate goal remains to decrease an HF patient's risk for hospital readmission, all from the comfort of the patient's home.
To meet this need, Eko has developed the DUO, an FDA-cleared, portable, hand-held, wirelessly connected medical device with ECG and sound sensors. Data from the DUO can be wirelessly streamed to a mobile phone or tablet, which can then be transmitted to a HIPAA-compliant internet cloud infrastructure for storage and analysis. In 2020, Eko introduced into the US market a package of AI/ML algorithms that follows this workflow to identify heart murmurs, atrial fibrillation, and other cardiac conditions, and intends after this proof of concept study to build upon this platform to estimate and trend PA pressures.
But beyond measuring and trending PA pressures, the DUO can be used to capture additional important HF features that will further improve any HF algorithm's performance. For example, because patients with decompensated HF often have an audible third heart sound, characteristic ECG findings, and altered time interval durations between their heart sounds and ECG signals, the Eko DUO device may be uniquely positioned to detect these types of changing signals.
In addition, because heart failure and fluid overload are reflected in the lungs as crackles (and occasionally effusions), the lung examination is and has always been a cornerstone of the overall physical examination of HF patients. By using the DUO to capture lung sounds in patients with HF, and comparing not only the presence or absence of crackles, but also how these adventitious sounds change over time, we will be able to explore the utility of the Eko DUO in helping to predict exacerbated HF.
This proof-of-concept study evaluates the feasibility of the Eko DUO in capturing and measuring signals relevant to HF exacerbation (e.g., time intervals, adventitious lungs sounds, pathologic heart sounds), as well as the feasibility of developing an AI/ML algorithm to model PA pressures in HF patients with the implantable CardioMEMS device.
- Conditions
- Heart Failure
- Being tested
- Eko DUO
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eko DUODevice
Each subject will take an Eko DUO device home and take DUO recordings immediately before or after their prescribed CardioMEMS measurements.
The DUO recordings will be taken at 3 predefined chest locations: the right upper sternal border, left upper sternal border, and right anterolateral. Each DUO recording lasts about 15 seconds. The total time per recording session is expected to be 2-4 minutes, which allows for time between recordings and any potential repeat recordings. Study participation will last for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Subjects with implanted CardioMEMS who are compliant with their measurements. Receives: Device: Eko DUO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between AI/ML model output and the ground-truth of CardioMEMS PA pressure measurements.
The primary objective of this proof of concept study is to demonstrate whether Eko data scientists can create an artificial intelligence machine learning (AI/ML) model of pulmonary artery (PA) pressures by analyzing sound and electrical (ECG) signals of heart activity captured by the non-invasive, FDA-cleared, Eko DUO electronic stethoscope.
Measured: 6 months
Secondary outcomes (2)
Composite of the incidence of poor-quality ECG or PCG data and tabulation of patient compliance with the data measurement schedule
A secondary objective of the study is to assess the usability of the Eko DUO by patients at home
Measured: 6 months
Intra-subject reproducibility of measured variables
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Feb 2021
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eko Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, Sentara Norfolk General Hospital
- Responsible party
- Sponsor
- Investigators
- Deepak Talreja, MD, Principal investigator, Sentara Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080504
- Sponsor's protocol ID
- 2022.1
- Status last verified
- Feb 2025
- First submitted
- 9 Sep 2021
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Brugts JJ, Veenis JF, Radhoe SP, Linssen GCM, van Gent M, Borleffs CJW, van Ramshorst J, van Pol P, Tukkie R, Spee RF, Emans ME, Kok W, van Halm V, Handoko L, Beeres SLMA, Post MC, Boersma E, Lenzen MJ, Manintveld OC, Koffijberg H, van Baal P, Versteegh M, Smilde TD, van Heerebeek L, Rienstra M, Mosterd A, Delnoy PPH, Asselbergs FW, Brunner-La Rocca HP, de Boer RA. A randomised comparison of the effect of haemodynamic monitoring with CardioMEMS in addition to standard care on quality of life and hospitalisations in patients with chronic heart failure : Design and rationale of the MONITOR HF multicentre randomised clinical trial. Neth Heart J. 2020 Jan;28(1):16-26. doi: 10.1007/s12471-019-01341-9.
PubMed 31776915Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
PubMed 21080835Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. No abstract available.
PubMed 22825412Dhruva SS, Krumholz HM. Championing Effectiveness Before Cost-Effectiveness. JACC Heart Fail. 2016 May;4(5):376-9. doi: 10.1016/j.jchf.2016.02.001. Epub 2016 Mar 30. No abstract available.
PubMed 27039130Givertz 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.
PubMed 28982501Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.
PubMed 20687083Johnston M, Collins SP, Storrow AB. The third heart sound for diagnosis of acute heart failure. Curr Heart Fail Rep. 2007 Sep;4(3):164-8. doi: 10.1007/s11897-007-0036-z.
PubMed 17883993Kilgore M, Patel HK, Kielhorn A, Maya JF, Sharma P. Economic burden of hospitalizations of Medicare beneficiaries with heart failure. Risk Manag Healthc Policy. 2017 May 10;10:63-70. doi: 10.2147/RMHP.S130341. eCollection 2017.
PubMed 28546776Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28.
PubMed 21444883Madias JE. The resting electrocardiogram in the management of patients with congestive heart failure: established applications and new insights. Pacing Clin Electrophysiol. 2007 Jan;30(1):123-8. doi: 10.1111/j.1540-8159.2007.00586.x.
PubMed 17241326Schmier JK, Ong KL, Fonarow GC. Cost-Effectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System. Clin Cardiol. 2017 Jul;40(7):430-436. doi: 10.1002/clc.22696. Epub 2017 Mar 8.
PubMed 28272808Sehatbakhsh, Samineh, Stephanie Hakimian, Yash Jobanputra, Rosmy Jimmy, Robert Chait, Mark Showronski, Kaustubh Kale, and Steven Borzak. 2018. "Assessment of LV Systolic Function Using Cardiac Time Intervals with an Acoustic Array Approach." Journal of Cardiac Failure 24 (8): S38.
Stehlik J, Schmalfuss C, Bozkurt B, Nativi-Nicolau J, Wohlfahrt P, Wegerich S, Rose K, Ray R, Schofield R, Deswal A, Sekaric J, Anand S, Richards D, Hanson H, Pipke M, Pham M. Continuous Wearable Monitoring Analytics Predict Heart Failure Hospitalization: The LINK-HF Multicenter Study. Circ Heart Fail. 2020 Mar;13(3):e006513. doi: 10.1161/CIRCHEARTFAILURE.119.006513. Epub 2020 Feb 25.
PubMed 32093506Sung, Shih-Hsien, Wen-Chung Yu, Hao-Min Cheng, Yu-Ping Chang, and Chen-Huan Chen. 2019. "USE OF ACOUSTIC CARDIOGRAPHY TO GUIDE OUTPATIENT THERAPY OF PATIENTS WITH ACUTE HEART FAILURE SYNDROME." Journal of the American College of Cardiology 63 (12 Supplement): A541.
Toukhsati SR, Driscoll A, Hare DL. Patient Self-management in Chronic Heart Failure - Establishing Concordance Between Guidelines and Practice. Card Fail Rev. 2015 Oct;1(2):128-131. doi: 10.15420/cfr.2015.1.2.128.
PubMed 28785446
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS)
- ClinicalTrials.gov ID
- NCT05080504
- Acronym / sponsor ID
- 2022.1
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Eko Devices, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, Sentara Norfolk General Hospital
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll heart failure (HF) patients who are under active management with an implanted pulmonary artery pressure sensor (CardioMEMS). Subjects will be provided an electronic stethoscope (the Eko DUO) to take at-home heart sound, lung sound, and ECG recordings in conjunction with regimented CardioMEMS measurements. These two datasets will be used to confirm whether an AI/ML model to track HF status can be developed.
Detailed description
Heart failure (HF) affects an estimated 6.2 million Americans over the age of 20 and carries a very high healthcare system burden worldwide. Annual costs for HF management in the United States were estimated at $30.7 billion in 2012 and are projected to increase to $68.7 billion by 2030. The primary cost driver for HF management is a high rate of acute decompensation and subsequent hospitalization. The mean per-patient cost of an HF-related hospitalization is estimated to be $14,631.
Among the conditions that the Centers of Medicare and Medicaid Services (CMS) monitors for their Hospital Readmission Reduction Program, HF has the highest median readmission rate at days 1-29 (23%) and days 1-60 (11.4%) postdischarge. The cost burden of HF readmission is $2.7 billion in 2013. A meta-analysis from 2012 estimated that 23.1% of HF readmissions are avoidable, although individual studies ranged from 5% to 79%. Many health plans, including CMS, have focused on interventions that monitor patients for early detection of HF decompensation. Earlier interventions can help care teams prevent avoidable hospitalizations.
Invasive hemodynamic sensor devices have enabled HF care teams to better predict and prevent HF decompensation events, and thus prevent rehospitalizations. One such device is the CardioMEMS pulmonary artery (PA) sensor (Abbott Inc., Atlanta, GA, USA). The CardioMEMS is implanted in a branch of the left PA, allowing for daily measurements of PA pressures. PA pressures are used as a surrogate marker of filling pressure, and rising filling pressures, in turn, are a marker that precedes the exacerbation of HF. The CHAMPIONS trial demonstrated that remote diuretic management using CardioMEMS reduced HF all-cause hospitalizations by 43% and mortality by 57%. Unfortunately, CardioMEMS as an HF solution is invasive, costly (average sales price of $17,750), indicated for a restricted patient population (NYHA class III HF who have been hospitalized within the last year), and has limited reimbursement coverage due to equivocal cost-effectiveness projections.
This has stimulated a search for less expensive, non-invasive sensors that may correlate with fluid status in HF patients. A study in Taiwan demonstrated that outpatient therapy guided by an inpatient device with ECG and sound sensors reduced post-discharge HF utilization by 31% when compared to a control group using symptoms to guide therapy. The LINK-HF study demonstrated that a wearable patch with ECG and sound sensors could predict HF readmissions with a sensitivity of 76% to 88%, a specificity of 85%, and a median lead time of 6.5 days.
Despite these initially promising results, however, these devices have significant disadvantages. The inpatient device used in the Taiwanese study could not be adapted into a portable form factor for outpatient use. Wearable devices can be rigid, uncomfortable, and highly visible, all of which can interfere with patient function and decrease monitoring compliance.
Therefore, there remains an unmet clinical need for a widely available, non-invasive, affordable medical device that can estimate an HF patient's hemodynamic fluid status and inform the HF care management team. The ultimate goal remains to decrease an HF patient's risk for hospital readmission, all from the comfort of the patient's home.
To meet this need, Eko has developed the DUO, an FDA-cleared, portable, hand-held, wirelessly connected medical device with ECG and sound sensors. Data from the DUO can be wirelessly streamed to a mobile phone or tablet, which can then be transmitted to a HIPAA-compliant internet cloud infrastructure for storage and analysis. In 2020, Eko introduced into the US market a package of AI/ML algorithms that follows this workflow to identify heart murmurs, atrial fibrillation, and other cardiac conditions, and intends after this proof of concept study to build upon this platform to estimate and trend PA pressures.
But beyond measuring and trending PA pressures, the DUO can be used to capture additional important HF features that will further improve any HF algorithm's performance. For example, because patients with decompensated HF often have an audible third heart sound, characteristic ECG findings, and altered time interval durations between their heart sounds and ECG signals, the Eko DUO device may be uniquely positioned to detect these types of changing signals.
In addition, because heart failure and fluid overload are reflected in the lungs as crackles (and occasionally effusions), the lung examination is and has always been a cornerstone of the overall physical examination of HF patients. By using the DUO to capture lung sounds in patients with HF, and comparing not only the presence or absence of crackles, but also how these adventitious sounds change over time, we will be able to explore the utility of the Eko DUO in helping to predict exacerbated HF.
This proof-of-concept study evaluates the feasibility of the Eko DUO in capturing and measuring signals relevant to HF exacerbation (e.g., time intervals, adventitious lungs sounds, pathologic heart sounds), as well as the feasibility of developing an AI/ML algorithm to model PA pressures in HF patients with the implantable CardioMEMS device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Device: Eko DUOSubjects with implanted CardioMEMS who are compliant with their measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified via the medical center's registry of patients who are actively managed with CardioMEMS. Alternatively, the center's schedule of CardioMEMS implantations will be monitored for potential subjects with newly implanted CardioMEMS.
Key inclusion criteria (6 listed)
- Aged 18 years and older
- Patient or healthcare proxy willing to give written informed consent to participate
- Presence of an implanted CardioMEMS device or imminent implantation of a CardioMEMS device
- Expressed willingness to take DUO recordings immediately before or after taking their CardioMEMS measurements, on the same schedule prescribed by their physician
- Functioning iOS or Android smartphone or tablet that can download and run the companion Eko application
Key exclusion criteria (4 listed)
- Patient or healthcare proxy is unwilling or unable to give written informed consent
- Patient is enrolled in another study that may interfere with the observations from this study
- Acute pericarditis
- Healing chest wall wounds (e.g., sternotomy or thoracotomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eko DUOEach subject will take an Eko DUO device home and take DUO recordings immediately before or after their prescribed CardioMEMS measurements. The DUO recordings will be taken at 3 predefined chest locations: the right upper sternal border, left upper sternal border, and right anterolateral. Each DUO recording lasts about 15 seconds. The total time per recording session is expected to be 2-4 minutes, which allows for time between recordings and any potential repeat recordings. Study participation will last for 90 days. | Device | Study Population |
Primary outcome
Correlation between AI/ML model output and the ground-truth of CardioMEMS PA pressure measurements.
Time frame: 6 months
The primary objective of this proof of concept study is to demonstrate whether Eko data scientists can create an artificial intelligence machine learning (AI/ML) model of pulmonary artery (PA) pressures by analyzing sound and electrical (ECG) signals of heart activity captured by the non-invasive, FDA-cleared, Eko DUO electronic stethoscope.
2 secondary outcomes
Composite of the incidence of poor-quality ECG or PCG data and tabulation of patient compliance with the data measurement schedule
Time frame: 6 months
Intra-subject reproducibility of measured variables
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 31776915Brugts JJ, Veenis JF, Radhoe SP, Linssen GCM, van Gent M, Borleffs CJW, van Ramshorst J, van Pol P, Tukkie R, Spee RF, Emans ME, Kok W, van Halm V, Handoko L, Beeres SLMA, Post MC, Boersma E, Lenzen MJ, Manintveld OC, Koffijberg H, van Baal P, Versteegh M, Smilde TD, van Heerebeek L, Rienstra M, Mosterd A, Delnoy PPH, Asselbergs FW, Brunner-La Rocca HP, de Boer RA. A randomised comparison of the effect of haemodynamic monitoring with CardioMEMS in addition to standard care on quality of life and hospitalisations in patients with chronic heart failure : Design and rationale of the MONITOR HF multicentre randomised clinical trial. Neth Heart J. 2020 Jan;28(1):16-26. doi: 10.1007/s12471-019-01341-9.
- Background: PubMed 21080835Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
- Background: PubMed 22825412Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. No abstract available.
- Background: PubMed 27039130Dhruva SS, Krumholz HM. Championing Effectiveness Before Cost-Effectiveness. JACC Heart Fail. 2016 May;4(5):376-9. doi: 10.1016/j.jchf.2016.02.001. Epub 2016 Mar 30. No abstract available.
- Background: PubMed 28982501Givertz 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.
- Background: PubMed 20687083Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.
- Background: PubMed 17883993Johnston M, Collins SP, Storrow AB. The third heart sound for diagnosis of acute heart failure. Curr Heart Fail Rep. 2007 Sep;4(3):164-8. doi: 10.1007/s11897-007-0036-z.
- Background: PubMed 28546776Kilgore M, Patel HK, Kielhorn A, Maya JF, Sharma P. Economic burden of hospitalizations of Medicare beneficiaries with heart failure. Risk Manag Healthc Policy. 2017 May 10;10:63-70. doi: 10.2147/RMHP.S130341. eCollection 2017.
- Background: PubMed 21444883Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28.
- Background: PubMed 17241326Madias JE. The resting electrocardiogram in the management of patients with congestive heart failure: established applications and new insights. Pacing Clin Electrophysiol. 2007 Jan;30(1):123-8. doi: 10.1111/j.1540-8159.2007.00586.x.
- Background: PubMed 28272808Schmier JK, Ong KL, Fonarow GC. Cost-Effectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System. Clin Cardiol. 2017 Jul;40(7):430-436. doi: 10.1002/clc.22696. Epub 2017 Mar 8.
- BackgroundSehatbakhsh, Samineh, Stephanie Hakimian, Yash Jobanputra, Rosmy Jimmy, Robert Chait, Mark Showronski, Kaustubh Kale, and Steven Borzak. 2018. "Assessment of LV Systolic Function Using Cardiac Time Intervals with an Acoustic Array Approach." Journal of Cardiac Failure 24 (8): S38.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Talreja, MD principal investigator
Sentara Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Eko Devices, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between AI/ML model output and the ground-truth of CardioMEMS PA pressure measurements. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080504, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.