RECRUITING

Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose for this study is to support the hypothesis (pilot data) that the use of the Sensinel CPM system reduces the rate of HF-related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the primary objective, the study will compare the outcomes and costs for patients using the Sensinel CPM system against those who are not. This can either be done using institutions' averages, if available, or through a control group.

Official Title

Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure

Quick Facts

Study Start:2023-09-22
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05650541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * NYHA Class III HF
  2. * NYHA Class IV HF
  3. * NYHA Class II HF with one or more of the following:
  4. * Chronic Kidney Disease (eGFR\<60 within the past 6 months)
  5. * 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 screening ECG+
  6. * NT-proBNP \> 300 pg/ml\* for patients not in AF or \> 900 pg/ml\* for patients in AF on the screening visit ECG+
  7. * Chronic obstructive pulmonary disease (COPD)
  1. * Under 18 years of age
  2. * Patients with severe COPD (GOLD stage III or IV)
  3. * Limited mobility preventing application of device or no caregiver to assist
  4. * Cognitive impairments that would limit the application and proper use of the device
  5. * Skin allergies or skin sensitivities to silicone-based adhesives
  6. * Pregnancy (method of assessment at the discretion of the PI)
  7. * Not willing to shave chest hair if needed to apply device
  8. * Patients on chronic IV ionotropic therapy - (Milrinone, Dobutamine, and Dopamine)
  9. * Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
  10. * No cellular coverage (Patient's Home)\*\*
  11. * Skin breakdown on the left chest or breast area

Contacts and Locations

Study Contact

Emily Wycallis
CONTACT
978-435-1644
emily.wycallis@analog.com

Study Locations (Sites)

Desert Oasis Healthcare
Palm Springs, California, 92262
United States
Baptist Health South Florida
Miami, Florida, 33173
United States
Orlando Health
Orlando, Florida, 32806
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68189
United States
Cone Health
Greensboro, North Carolina, 27401
United States
Prisma Health
Greenville, South Carolina, 29601
United States

Collaborators and Investigators

Sponsor: Analog Device, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure