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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioMEMS HF System Coverage With Evidence Development Study
- ClinicalTrials.gov ID
- NCT06779552
- Acronym / sponsor ID
- CL1027482
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: CardioMEMS HF SystemHeart failure patients implanted with the CardioMEMS PA pressure sensor. |
| Control Group | – | –Heart failure patients being managed without PA pressure-monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioMEMS HF SystemPA Pressure Sensor | Device | Treatment Group |
Primary outcome
HF Hospitalization Rate.
Time frame: 2 years
Compare HF hospitalization rate between the treatment and control groups.
1 secondary outcome
Two-Year Survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nessa Johnson (612-283-3865, nessa.johnson@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HF Hospitalization Rate. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.