Heart FailureNCT06024369
Study of ADI CardioPulmonary Management (CPM) System
A study testing CPM Device in people with Heart Failure, run by Analog Device, Inc. at 1 site in United States.
Trial summary
This study is meant primarily collect CardioPulmonary Management (CPM) data from daily usage and compare it to the clinical course of a patient. For this study, the only aspect of the CPM solution that will be used will be the device itself and the mobile application to assign devices to patients. 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?
- CPM Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Mar 2024
- Phase
- Interventional
- 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
Who may be able to join
None listed.
Who cannot join
- Under 18 years of age
- Patients with severe COPD (GOLD stage III or IV)
- Limited mobility preventing application of device or no caregiver to assist
- Cognitive impairments that would limit the application and proper use of the device
- Skin allergies or skin sensitivities to silicone-based adhesives
- Pregnancy (method of assessment at the discretion of the PI)
Show all 11Show fewer
- Not willing to shave chest hair if needed to apply device
- Patients on chronic IV (intravenous) ionotropic therapy - (Milrinone, Dobutamine, and Dopamine)
- Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
- No cellular coverage (Patient's Home)**
- Skin breakdown on the left chest or breast area
Trial locations and contacts
1 site in 1 country.
About this study
This study is meant primarily collect CardioPulmonary Management (CPM) data from daily usage and compare it to the clinical course of a patient. For this study, the only aspect of the CPM solution that will be used will be the device itself and the mobile application to assign devices to patients. The patients will be assigned a device at visit one and take the device home. They will use the device once daily (when they first wake up) for 6 months. The patient will come in for visit 2 to return the device.
Read the detailed description
Patients that participate in this study will be using a wearable device for 6 months. At their initial visit (visit 1), patients will undergo a brief physical exam, have their medical history and medications recorded, and be fit to a device. With their clinical (or clinician delegate), the patient will have their baseline reading with the device. The patient will then be taught how to use the device at home and go through 2 practice patient-initiated measurements. The patient will also complete two surveys as a part of visit 1. These surveys can be done at the visit or at home within 7 days of the visit.
Details of all available history of Chronic Heart Failure (CHF) disease including surgical interventions related to CHF, CHF risk factors, or CHF comorbidities will be recorded (via a chart pull after the visit). The number of previous CHF-related hospitalizations, the patient's latest CHF diagnosis classification, and date of last hospitalization (number of days since) will be specifically noted. This includes notes about the current condition of the patient and their congestion and fluid status. Current New York Heart Association (NYHA) classification will be pulled as well (or assigned during the physical exam portion). Recent BNP (brain natriuretic peptide), creatinine, Left Ventricular Ejection Fraction (LVEF), chest Xray and other relevant labs will also be pulled from the chart and with vaccination status and dates for the following vaccines: COVID 19, flu and pneumonia. This is the first chart review (of two) that is required for the study).
After visit 1, the patient will use the device once daily for 6 months. After 6 months, the patient will return for visit 2. At visit two, the patient will have a brief physical exam and return the device. The patient will complete the same two surveys and an additional survey about their perception of the device.
30 days after visit 2 a second, targeted chart review will occur. Details of the patient's clinical course while they were using the device and for an additional 30 days after will be recorded. While the chart review will be targeted to the CHF clinical course (such as Emergency room visits, hospitalizations, skilled nursing facility visits, outpatient checkups and other CHF related notes), other relevant information will be collected as well. The most recent NYHA classification will be pulled (or assigned at visit 2). The most recent BNP, creatinine, LVEF, chest Xray and other relevant labs will be pulled.
- Conditions
- Heart Failure
- Being tested
- CPM Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPM DeviceDevice
Wearable monitor used for 5 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Using wearable CPM Device daily | Experimental | The patients will be using the wearable device once daily at home for 6 months. Receives: Device: CPM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction with Device
Patient satisfaction with system obtained through survey questions; ease of use, impact and satisfaction; scale of 1-7 used with 1 being negative and 7 being positive. Higher scores indicate more satisfaction with device.
Measured: 6 months
Correlation of device data and clinical outcomes
Retrospective review of data to determine correlation of patient specific device measurements (such as increase/decrease in specific device parameters) with heart failure events. Measurements include thoracic impedance, respiration rate (RR), heart rate (HR), relative tidal volume (rTV), RR variability, HR variability, RR/rTV, QRS width, QTc width, presence of atrial fibrillation, and diastolic heart sound strength
Measured: 7 months
Patient Quality of Life
Patient quality of live measured through the Minnesota Living with Heart Failure questionnaire. The questionnaire measures how heart failure impacts the patient's life scale is 0-5. 0 is does not apply, 1 is very little and 5 is very much. Higher scores indicate a worse quality of life.
Measured: 6 months
Secondary outcomes (1)
Compliance rates
Percent of days with at least one measurement
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 posted6 Sep 2023
- Study start1 Mar 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Change in staff / resources, sponsor decided not to pursue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Analog Device, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024369
- Sponsor's protocol ID
- TUFTS-PILOT-1.0
- Status last verified
- May 2024
- First submitted
- 28 Aug 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of ADI CardioPulmonary Management (CPM) System
- ClinicalTrials.gov ID
- NCT06024369
- Acronym / sponsor ID
- TUFTS-PILOT-1.0
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in staff / resources, sponsor decided not to pursue study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Analog Device, Inc.University, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 6 Sep 2023 (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 is meant primarily collect CardioPulmonary Management (CPM) data from daily usage and compare it to the clinical course of a patient. For this study, the only aspect of the CPM solution that will be used will be the device itself and the mobile application to assign devices to patients. The patients will be assigned a device at visit one and take the device home. They will use the device once daily (when they first wake up) for 6 months. The patient will come in for visit 2 to return the device.
Detailed description
Patients that participate in this study will be using a wearable device for 6 months. At their initial visit (visit 1), patients will undergo a brief physical exam, have their medical history and medications recorded, and be fit to a device. With their clinical (or clinician delegate), the patient will have their baseline reading with the device. The patient will then be taught how to use the device at home and go through 2 practice patient-initiated measurements. The patient will also complete two surveys as a part of visit 1. These surveys can be done at the visit or at home within 7 days of the visit.
Details of all available history of Chronic Heart Failure (CHF) disease including surgical interventions related to CHF, CHF risk factors, or CHF comorbidities will be recorded (via a chart pull after the visit). The number of previous CHF-related hospitalizations, the patient's latest CHF diagnosis classification, and date of last hospitalization (number of days since) will be specifically noted. This includes notes about the current condition of the patient and their congestion and fluid status. Current New York Heart Association (NYHA) classification will be pulled as well (or assigned during the physical exam portion). Recent BNP (brain natriuretic peptide), creatinine, Left Ventricular Ejection Fraction (LVEF), chest Xray and other relevant labs will also be pulled from the chart and with vaccination status and dates for the following vaccines: COVID 19, flu and pneumonia. This is the first chart review (of two) that is required for the study).
After visit 1, the patient will use the device once daily for 6 months. After 6 months, the patient will return for visit 2. At visit two, the patient will have a brief physical exam and return the device. The patient will complete the same two surveys and an additional survey about their perception of the device.
30 days after visit 2 a second, targeted chart review will occur. Details of the patient's clinical course while they were using the device and for an additional 30 days after will be recorded. While the chart review will be targeted to the CHF clinical course (such as Emergency room visits, hospitalizations, skilled nursing facility visits, outpatient checkups and other CHF related notes), other relevant information will be collected as well. The most recent NYHA classification will be pulled (or assigned at visit 2). The most recent BNP, creatinine, LVEF, chest Xray and other relevant labs will be pulled.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Using wearable CPM Device daily | Experimental | Device: CPM DeviceThe patients will be using the wearable device once daily at home for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Under 18 years of age
- Patients with severe COPD (GOLD stage III or IV)
- Limited mobility preventing application of device or no caregiver to assist
- Cognitive impairments that would limit the application and proper use of the device
- Skin allergies or skin sensitivities to silicone-based adhesives
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 |
|---|---|---|
| CPM DeviceWearable monitor used for 5 minutes per day. | Device | Using wearable CPM Device daily |
Primary outcome
Patient Satisfaction with Device
Time frame: 6 months
Patient satisfaction with system obtained through survey questions; ease of use, impact and satisfaction; scale of 1-7 used with 1 being negative and 7 being positive. Higher scores indicate more satisfaction with device.
Correlation of device data and clinical outcomes
Time frame: 7 months
Retrospective review of data to determine correlation of patient specific device measurements (such as increase/decrease in specific device parameters) with heart failure events. Measurements include thoracic impedance, respiration rate (RR), heart rate (HR), relative tidal volume (rTV), RR variability, HR variability, RR/rTV, QRS width, QTc width, presence of atrial fibrillation, and diastolic heart sound strength
Patient Quality of Life
Time frame: 6 months
Patient quality of live measured through the Minnesota Living with Heart Failure questionnaire. The questionnaire measures how heart failure impacts the patient's life scale is 0-5. 0 is does not apply, 1 is very little and 5 is very much. Higher scores indicate a worse quality of life.
1 secondary outcome
Compliance rates
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPM Device in people with Heart Failure, run by Analog Device, Inc. at 1 site 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 0 inclusion and 11 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: withdrawn, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Patient Satisfaction with Device (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.