Heart FailureNCT06779552
CardioMEMS HF System Coverage With Evidence Development Study
An observational study of Heart Failure, run by Abbott Medical Devices at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CardioMEMS HF System
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2025to Mar 2032
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
- Subject >=18 years of age at time of implant
- 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
Who cannot join
- Subject has history of heart transplant or durable mechanical circulatory device
- Subject hospitalized with cardiogenic shock or sepsis
- Subject received prior PA pressure sensor implant (control arm only)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abbott
Pleasanton, California, 94588
Nessa Johnson, 612-283-3865, nessa.johnson@abbott.com
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- CardioMEMS HF System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMEMS HF SystemDevice
PA Pressure Sensor
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Heart failure patients implanted with the CardioMEMS PA pressure sensor. Receives: Device: CardioMEMS HF System | |
| Control Group | Heart failure patients being managed without PA pressure-monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF Hospitalization Rate.
Compare HF hospitalization rate between the treatment and control groups.
Measured: 2 years
Secondary outcomes (1)
Two-Year Survival
Compare survival between the treatment and control groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start7 Feb 2025
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779552
- Sponsor's protocol ID
- CL1027482
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes