CardioMEMS HF System Coverage with Evidence Development Study

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.

Conditions

Heart Failure

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

CardioMEMS HF System Coverage with Evidence Development Study

CardioMEMS HF System Coverage with Evidence Development Study

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Pleasanton

Abbott, Pleasanton, California, United States, 94588

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
  • 2. Subject \>=18 years of age at time of implant
  • 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. Subject has history of heart transplant or durable mechanical circulatory device
  • 2. Subject hospitalized with cardiogenic shock or sepsis
  • 3. Subject received prior PA pressure sensor implant (control arm only)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Study Record Dates

2032-03