RECRUITING

Clinical Data Collection Study Using CPM System

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

This study will assess the deployment of the ADI CPM System in a home setting and determine the interoperability of the CPM System within existing care pathways for HF patients. Clinicians will be blinded to CPM generated data and acquired physiologic data will not be used in clinical decision-making. After conclusion of this phase, a retrospective review of CPM System-acquired data will be compared with changes in treatment and HF events. This retrospective review will inform the subsequent design of the interventional study that is planned. Study participation for each patient will last for six months inclusive of 5 months of daily CPM monitoring followed by 30 days of observation for HF-related events. The additional 30 days of medical record observation is intended to capture any events that might correspond to predictions made during the final weeks of CPM monitoring.

Official Title

Clinical Data Collection Study Using CardioPulmonary Management System in Patients With Chronic Heart Failure

Quick Facts

Study Start:2023-12-06
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06007079

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-IV
  2. * NYHA Class II HF with one or more of the following:
  3. * Chronic Kidney Disease (eGFR\<60)
  4. * 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/m for patients in AF on screening ECG
  5. * NT-proBNP \> 300 pg/ml for patients not in AF or \> 900 pg/ml for patients in AF on the screening visit ECG.
  6. * Chronic obstructive pulmonary disease (COPD)
  1. * Under 18 years of age
  2. * Patients with severe COPD (GOLD stage III or IV)
  3. * Chronic Kidney Disease (eGFR \< 20)
  4. * Limited mobility preventing application of device
  5. * Cognitive impairments that would limit the application and proper use of the device
  6. * Skin allergies or skin sensitivities to silicone-based adhesives
  7. * Pregnancy
  8. * Skin breakdown on the left chest or breast area
  9. * Not willing to shave chest hair if needed to apply device
  10. * Patients on chronic inotropic therapy
  11. * Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
  12. * No cellular coverage (Patient's Home)

Contacts and Locations

Study Contact

Emily Wycallis
CONTACT
9784351644
emily.wycallis@analog.com

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
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 Date2023-12-06
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-12-06
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure