CardioMEMS HF System Coverage With Evidence Development Study

March 30, 2026 updated by: Abbott Medical Devices
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include Heart Failure patients in the United States implanted with the CardioMEMS PA pressure sensor and HF patients being managed without PA pressure-monitoring.

Description

Inclusion 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

Exclusion Criteria:

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
Heart failure patients implanted with the CardioMEMS PA pressure sensor.
Device: CardioMEMS HF System
PA Pressure Sensor
Control Group
Heart failure patients being managed without PA pressure-monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HF Hospitalization Rate.
Time Frame: 2 years
Compare HF hospitalization rate between the treatment and control groups.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two-Year Survival
Time Frame: 2 years
Compare survival between the treatment and control groups.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

February 7, 2025

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1027482

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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