CardioMEMS European Monitoring Study for Heart Failure

A study testing CardioMEMS HF System in people with Heart Failure, run by Abbott Medical Devices at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 239 participants
Where: 2 sitesGermany
Study dates: May 2016to 1 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
≥ 18 years of age
Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
Written informed consent obtained from subject

Who cannot join

Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Klinukum Coburg
Coburg, Bavaria, 96450
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080

Other trials in Germany

About this study

The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.

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
Pulmonary Artery Pressure Monitoring

Study groups in NCT02693691
Study group	Role	What they receive
CardioMEMS HF System	Experimental	Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. Receives: Device: CardioMEMS HF System

What is being measured

The primary outcome is the main question the study is designed to answer.

Freedom From Device/System Related Complications
This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant.
Measured: one year
Freedom From Pressure Sensor Failure
This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.
Measured: one year
Percent of Successful Pulmonary Artery Pressure Data Transmissions
Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months.
Measured: one year

Secondary outcomes (1)

Heart Failure Hospitalization (HFH) Rate
Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant.
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 20161 Mar 2020

First posted29 Feb 2016 (estimated)
Study startMay 2016
Primary completion31 Mar 2019
Study completion1 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02693691
Sponsor's protocol ID: SJM-CIP-10105
Acronym: MEMS-HF
Status last verified: Apr 2022
First submitted: 20 Feb 2016
Last updated: 5 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.
PubMed 40223608
Bohm M, Assmus B, Anker SD, Asselbergs FW, Brachmann J, Brett ME, Brugts JJ, Ertl G, Wang A, Hilker L, Koehler F, Rosenkranz S, Leistner DM, Abdin A, Wintrich J, Zhou Q, Adamson PB, Angermann CE. Less loop diuretic use in patients on sacubitril/valsartan undergoing remote pulmonary artery pressure monitoring. ESC Heart Fail. 2022 Feb;9(1):155-163. doi: 10.1002/ehf2.13665. Epub 2021 Nov 4.
PubMed 34738340
Angermann CE, Assmus B, Anker SD, Brachmann J, Ertl G, Kohler F, Rosenkranz S, Tschope C, Adamson PB, Bohm M. Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF). Clin Res Cardiol. 2018 Nov;107(11):991-1002. doi: 10.1007/s00392-018-1281-8. Epub 2018 May 19.
PubMed 29777373

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CardioMEMS European Monitoring Study for Heart Failure
ClinicalTrials.gov ID: NCT02693691
Acronym / sponsor ID: MEMS-HF / SJM-CIP-10105
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: May 2016
Primary completion: 31 Mar 2019 (actual)
Study completion: 1 Mar 2020 (actual)
First posted: 29 Feb 2016 (estimated)
Results: Posted 14 Aug 2020

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 study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CardioMEMS HF System	Experimental	Device: CardioMEMS HF SystemSubjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
≥ 18 years of age
Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated

Key exclusion criteria (2 listed)

Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up

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 SystemPulmonary Artery Pressure Monitoring	Device	CardioMEMS HF System

Primary outcome

Freedom From Device/System Related Complications
Time frame: one year
This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant.
Freedom From Pressure Sensor Failure
Time frame: one year
This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.
Percent of Successful Pulmonary Artery Pressure Data Transmissions
Time frame: one year
Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months.

1 secondary outcome

Heart Failure Hospitalization (HFH) Rate
Time frame: one year

Results and safety

Results posted to the registry on 14 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CardioMEMS HF System	234	184

Primary outcome: Freedom From Device/System Related Complications

Time frame: one year. Number (95% Confidence Interval). Unit: percentage of patients

Measure	CardioMEMS HF System n = 239
Value	98.3 (95.8 to 100)

Population analysed: Safety population

Primary outcome: Freedom From Pressure Sensor Failure

Time frame: one year. Number (95% Confidence Interval). Unit: percentage of patients

Measure	CardioMEMS HF System n = 239
Value	99.6 (97.6 to 100)

Population analysed: Safety population

Primary outcome: Percent of Successful Pulmonary Artery Pressure Data Transmissions

Time frame: one year. Mean (Standard Deviation). Unit: percentage of successful transmissions

Measure	CardioMEMS HF System n = 234
Value	91.7 (13.0)

Population analysed: All subjects who were consented and implanted with a pressure sensor regardless of study completion status were included in the analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected starting from enrollment and until the last patient completed 12 months follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CardioMEMS HF System	184 of 239 (77%)	0 of 0	42 of 234

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40223608Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.
Derived from this study: PubMed 34738340Bohm M, Assmus B, Anker SD, Asselbergs FW, Brachmann J, Brett ME, Brugts JJ, Ertl G, Wang A, Hilker L, Koehler F, Rosenkranz S, Leistner DM, Abdin A, Wintrich J, Zhou Q, Adamson PB, Angermann CE. Less loop diuretic use in patients on sacubitril/valsartan undergoing remote pulmonary artery pressure monitoring. ESC Heart Fail. 2022 Feb;9(1):155-163. doi: 10.1002/ehf2.13665. Epub 2021 Nov 4.
Derived from this study: PubMed 29777373Angermann CE, Assmus B, Anker SD, Brachmann J, Ertl G, Kohler F, Rosenkranz S, Tschope C, Adamson PB, Bohm M. Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF). Clin Res Cardiol. 2018 Nov;107(11):991-1002. doi: 10.1007/s00392-018-1281-8. Epub 2018 May 19.
Individual participant dataSharing planned: Undecided

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

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. This study is not recruiting at the moment.

Christiane Angermann, Prof. Dr. principal investigator

Deutsches Zentrum für Herzinsuffizienz Würzburg

Michael Boehm, Prof. Dr. principal investigator

University Hospital, Saarland

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CardioMEMS HF System in people with Heart Failure, run by Abbott Medical Devices at 2 sites in Germany.

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 2 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: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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?

Yes. Results are posted in the registry (first posted 14 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Freedom From Device/System Related Complications (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02693691, which also lists 3 linked publications.

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 5 Apr 2022.