Heart Failure NYHA Class IINCT06306573
CardioMEMS HF System Real-World Evidence Post-Approval Study
An observational study of Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class II, Heart Failure NYHA Class III
- What is being tested?
- CardioMEMS HF System
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 31 Dec 2029
- 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 intended population for this RWE PAS includes Medicare FFS beneficiaries with symptomatic NYHA Class II and III heart failure implanted with a CardioMEMS PA Sensor in the commercial setting.
Who may be able to join
- Subject implanted with a CardioMEMS PA Sensor and enrolled in Merlin.net
- Subject resides in the United States as documented in Merlin.net
- NYHA Class II or Class III as documented in Merlin.net at the time of CardioMEMS implant (only NYHA Class II subjects contribute to the Primary Cohort)
- Subject identified in Merlin.net data can be linked to Medicare FFS claims
- Subject is enrolled in Medicare Part A and B, and not enrolled in Medicare Part C, at implant and for 12 months prior to implant, to establish qualification for CardioMEMS
- Subject ≥18 years of age at time of CardioMEMS implant
Who cannot join
- Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: CardioMEMS™ HF System Real-World Evidence Post-Approval Study
The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.
Read the detailed description
Subjects will be identified in Abbott's Merlin.net remote monitoring database. Merlin.net data will be linked to Medicare fee-for-service (FFS) claims data to longitudinally track outcomes. Each subject will be followed for a minimum of 36 months.
- Being tested
- CardioMEMS HF System
- Keywords
- CardioMEMS HF System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMEMS HF SystemDevice
The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data to monitor and manage HF subjects. The CardioMEMS HF System measures PA pressure which clinicians use to initiate or modify HF treatment.
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort | The Primary Cohort will include NYHA Class II heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting. Receives: Device: CardioMEMS HF System | |
| Full Cohort | The Full Cohort will include both NYHA Class II and Class III heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting. Receives: Device: CardioMEMS HF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-Year Survival in NYHA Class II subjects without a history of severe renal disease
Compare survival in a subset of subjects from the Primary Cohort without a history of severe renal disease to a pre-specified performance goal of 71.7% survival at 2 years
Measured: 2 years
Secondary outcomes (1)
Two-Year Survival in NYHA Class II and III subjects without a history of severe renal disease
Compare survival in a subset of subjects from the Full Cohort without a history of severe renal disease to a pre-specified performance goal of 68.6% survival at 2 years
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 posted12 Mar 2024
- Study start15 Dec 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIStudies 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
- 2,500 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
- NCT06306573
- Sponsor's protocol ID
- CL1019613
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioMEMS™ HF System Real-World Evidence Post-Approval Study
- ClinicalTrials.gov ID
- NCT06306573
- Acronym / sponsor ID
- CL1019613
- Keywords
- CardioMEMS HF System
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Mar 2024 (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 this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.
Detailed description
Subjects will be identified in Abbott's Merlin.net remote monitoring database. Merlin.net data will be linked to Medicare fee-for-service (FFS) claims data to longitudinally track outcomes. Each subject will be followed for a minimum of 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort | – | Device: CardioMEMS HF SystemThe Primary Cohort will include NYHA Class II heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting. |
| Full Cohort | – | Device: CardioMEMS HF SystemThe Full Cohort will include both NYHA Class II and Class III heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The intended population for this RWE PAS includes Medicare FFS beneficiaries with symptomatic NYHA Class II and III heart failure implanted with a CardioMEMS PA Sensor in the commercial setting.
Key inclusion criteria (6 listed)
- Subject implanted with a CardioMEMS PA Sensor and enrolled in Merlin.net
- Subject resides in the United States as documented in Merlin.net
- NYHA Class II or Class III as documented in Merlin.net at the time of CardioMEMS implant (only NYHA Class II subjects contribute to the Primary Cohort)
- Subject identified in Merlin.net data can be linked to Medicare FFS claims
- Subject is enrolled in Medicare Part A and B, and not enrolled in Medicare Part C, at implant and for 12 months prior to implant, to establish qualification for CardioMEMS
Key exclusion criteria (1 listed)
- Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant
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 SystemThe CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data to monitor and manage HF subjects. The CardioMEMS HF System measures PA pressure which clinicians use to initiate or modify HF treatment. | Device | Full Cohort, Primary Cohort |
Primary outcome
Two-Year Survival in NYHA Class II subjects without a history of severe renal disease
Time frame: 2 years
Compare survival in a subset of subjects from the Primary Cohort without a history of severe renal disease to a pre-specified performance goal of 71.7% survival at 2 years
1 secondary outcome
Two-Year Survival in NYHA Class II and III subjects without a history of severe renal disease
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 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NYHA Class II and Heart Failure NYHA Class III, 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 6 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 9 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-Year Survival in NYHA Class II subjects without a history of severe renal disease (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 9 Jul 2026.