RECRUITING

CardioMEMS HF System Coverage with Evidence Development Study

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 purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.

Official Title

CardioMEMS HF System Coverage with Evidence Development Study

Quick Facts

Study Start:2025-02-07
Study Completion:2032-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06779552

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. 1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
  2. 2. Subject \>=18 years of age at time of implant
  3. 3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP/NT-proBNP
  1. 1. Subject has history of heart transplant or durable mechanical circulatory device
  2. 2. Subject hospitalized with cardiogenic shock or sepsis
  3. 3. Subject received prior PA pressure sensor implant (control arm only)

Contacts and Locations

Study Contact

Nessa Johnson
CONTACT
612-283-3865
nessa.johnson@abbott.com

Study Locations (Sites)

Abbott
Pleasanton, California, 94588
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

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 Date2032-03

Study Record Updates

Study Start Date2025-02-07
Study Completion Date2032-03

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure