RECRUITING

Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure

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 retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.

Official Title

The Real-World Effectiveness of The Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy

Quick Facts

Study Start:2025-02-07
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06783335

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. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only)
  2. * Record of temporary mechanical circulatory support during baseline period
  3. * Diagnosis of cardiogenic shock during baseline period
  4. * Receiving palliative care/hospice during baseline period
  5. * Record of end-stage renal disease during baseline period
  6. * Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)

Contacts and Locations

Study Contact

Joanna Van Houten, PhD
CONTACT
949-250-6778
joanna_vanhouten@edwards.com
Harry Rowland, PhD
CONTACT
harry.rowland@endotronix.com

Principal Investigator

Joanna Van Houten, PhD
PRINCIPAL_INVESTIGATOR
Endotronix, Inc.

Study Locations (Sites)

Endotronix
Naperville, Illinois, 60563
United States

Collaborators and Investigators

Sponsor: Endotronix, Inc.

  • Joanna Van Houten, PhD, PRINCIPAL_INVESTIGATOR, Endotronix, 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 Date2025-02-07
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2025-02-07
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Heart failure
  • Heart Disease
  • Pulmonary Artery Pressure Sensor
  • Cardiovascular Disease
  • Cordella

Additional Relevant MeSH Terms

  • Heart Failure NYHA Class III
  • Heart Failure