Trial studying safety and effects for Heart Failure
Official title Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure
ClinicalTrials.gov ID: NCT05650541
What this study is testing
- What it's testing
- The study wants to find out if using the Sensinel CardioPulmonary Management system can reduce heart‑failure related events and lower healthcare costs, and whether it improves care quality and patient satisfaction.
- Who it's for
- It is looking for adults who have chronic heart failure.
- What's involved
- Participants will use the Sensinel CPM device and will be monitored for heart‑failure events and costs. Some may be compared to a control group or institutional averages.
- Time commitment
- The study will last for a period of time during which participants will have regular visits and monitoring, but the exact length and number of visits are not specified in the source.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- NYHA Class III HF
- NYHA Class IV HF OR
- Chronic Kidney Disease (eGFR\<60 within the past 6 months)
- HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP \> 200...
- NT-proBNP \> 300 pg/ml\ for patients not in AF or \> 900 pg/ml\ for patients in AF on the screening visit ECG+
You likely can't join if
- 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)
See the full eligibility criteria
- NYHA Class III HF
- NYHA Class IV HF OR
- Chronic Kidney Disease (eGFR\<60 within the past 6 months)
- HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP \> 200 pg/ml\ for patients not in AF or \> 600 pg/ml\ for patients in AF on...
- NT-proBNP \> 300 pg/ml\ for patients not in AF or \> 900 pg/ml\ for patients in AF on the screening visit ECG+
- Chronic obstructive pulmonary disease (COPD)
- 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)
- Not willing to shave chest hair if needed to apply device
- Patients on chronic IV 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
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- Orlando, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States; Orlando, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.