CardioMEMS Monitoring for Heart Failure

(SELFIe-HF Trial)

Overseen By Hélène Brown, BSc CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montreal Heart Institute

Must be taking: Diuretics

Must not be taking: Anticoagulants

Disqualifiers: Recent cardiovascular event, Severe valve lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should be on diuretics, so you may need to continue those if you are already taking them.

What data supports the effectiveness of the CardioMEMS HF System treatment for heart failure?

Research shows that the CardioMEMS device can improve quality of life and reduce hospitalizations for heart failure patients by monitoring heart and lung pressures remotely. However, some experts have raised concerns about its effectiveness in certain patient groups. ^{1 2 3 4 5}

Is the CardioMEMS HF System safe for use in humans?

The CardioMEMS HF System is generally considered safe for use in heart failure patients, as noted by the FDA panel in 2011. However, there have been rare cases of complications, such as pulmonary artery injury during sensor placement. ^{2 3 4 6 7}

How is the CardioMEMS treatment different from other heart failure treatments?

The CardioMEMS HF System is unique because it is an implantable device that wirelessly monitors pulmonary artery pressure, allowing for remote management of heart failure. This proactive approach helps reduce hospitalizations by alerting healthcare providers to changes in pressure before symptoms worsen, unlike traditional treatments that often react to symptoms after they appear. ^{1 2 3 4 6}

What is the purpose of this trial?

This trial tests a small device that monitors heart pressure and sends data to doctors remotely. It targets heart failure patients who have had hospitalizations. The goal is to see if this remote monitoring can reduce hospital visits and improve patient outcomes. A recently approved implantable wireless monitor has been shown to be effective in reducing hospitalizations among heart failure patients.

Research Team

Anique Ducharme

Principal Investigator

Montreal Heart Institute

Jean Rouleau, MD

Principal Investigator

Montreal Heart Institute

Eligibility Criteria

Adults over 18 with chronic heart failure, able to use a smartphone or iPad for self-management. They must have had a recent hospital visit for heart failure and meet specific criteria like PA branch diameter and NT-proBNP levels. Excluded are those with recent major cardiovascular events, severe conditions, certain medication intolerances, or who are pregnant.

Inclusion Criteria

I have had heart failure for at least 3 months.

My pulmonary artery size and my body structure meet the specific requirements.

I have heart failure symptoms and was hospitalized for it in the last year.

Exclusion Criteria

I have severe heart failure, may have a heart pump, or am waiting for a heart transplant.

I've had a recent heart issue or stroke, or I'm scheduled for heart surgery.

I have had a pulmonary embolism or recurrent deep vein thrombosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics

12 months

Regular remote follow-ups by a nurse clinician

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• CardioMems

Trial Overview The trial is testing if managing heart failure through a virtual clinic using Pulmonary Artery Pressure monitoring leads to fewer hospital visits and better outcomes compared to standard care. It also evaluates the safety and cost-effectiveness of this approach in patients with different severities of heart failure.

Participant Groups

Group I: CardioMems Active Control 1 Intervention

The treatment group will be implanted with a CardioMEMS HF sensor and managed using remote access to hemodynamics compared to a non-implanted control group.

Group II: Control Active Control 1 Intervention

Heart failure clinic follow up

CardioMems is already approved in United States, European Union for the following indications:

Approved in United States as CardioMEMS HF System for:

• Heart failure with preserved ejection fraction (HFpEF)
• Heart failure with reduced ejection fraction (HFrEF)

Approved in European Union as CardioMEMS HF System for:

• Heart failure with preserved ejection fraction (HFpEF)
• Heart failure with reduced ejection fraction (HFrEF)

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials

125

Recruited

85,400+

Findings from Research

The CardioMEMS device has been shown to significantly reduce heart failure-related hospitalizations, with a 28% reduction at 6 months and a 37% reduction over an average follow-up of 15 months, based on the CHAMPION trial involving targeted pulmonary artery pressure management.

In a recent post-approval study, the CardioMEMS device demonstrated an impressive 58% reduction in heart failure hospitalizations per patient year, indicating its effectiveness in improving patient outcomes and quality of life, especially for those with persistent symptoms despite optimal medical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Role of the CardioMEMS Device for Management of Patients with Heart Failure. Leung, CC.[2020]

The CardioMEMS Champion Heart Failure Monitoring System is considered safe for heart failure patients, as determined by the FDA Circulatory System Device Panel during its review for premarket approval.

Despite its safety, concerns were raised about the device's efficacy, particularly regarding potential bias in efficacy analysis and its effectiveness in certain patient subpopulations, leading to a lack of reasonable assurance of its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System. Loh, JP., Barbash, IM., Waksman, R.[2019]

CardioMEMS™ is an implantable device that has gained significant research interest for its role in monitoring heart failure (HF) patients.

The consensus from the European Society of Cardiology highlights the importance of device-based monitoring tools like CardioMEMS™ in improving treatment and management of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable devices for heart failure monitoring: the CardioMEMS™ system. Volterrani, M., Spoletini, I., Angermann, C., et al.[2020]

The CardioMEMS heart failure system, while beneficial for monitoring pulmonary artery pressures, carries a risk of serious complications such as pulmonary artery injury and haemoptysis during implantation, as demonstrated in a case involving an 80-year-old patient.

In this case, a pseudoaneurysm was successfully treated with transcatheter embolization, highlighting this method as a safe and effective option for managing such complications in stable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large pulmonary artery pseudoaneurysm after CardioMEMS implantation: a case report. Garg, T., Raikhelkar, J., Gilkeson, R., et al.[2022]

The CardioMEMS HF System, a device for remote monitoring of pulmonary artery pressure, has shown safety data in European studies that align with findings from U.S. studies, indicating it is safe for use in chronic heart failure patients.

While preliminary efficacy data suggest that CardioMEMS may reduce hospitalizations for heart failure, this is primarily based on observational studies; the upcoming MONITOR HF randomized clinical trial will provide more definitive evidence in a European context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CardioMEMS Heart Failure System for chronic heart failure - a European perspective. Radhoe, SP., Clephas, PRD., Mokri, H., et al.[2023]

The CardioMEMS HF system allows patients to monitor their pulmonary artery pressure remotely, which helps healthcare providers respond quickly to changes in their condition.

Patient adherence to the CardioMEMS system is influenced more by their self-concept than by the perceived benefits of the system, indicating that personal beliefs about oneself may play a crucial role in how consistently patients use telemonitoring devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding adherence to the CardioMEMS pulmonary artery pressure monitoring system for heart failure: A qualitative study. Haynes, SC., Pallin, R., Tong, K., et al.[2020]

The CardioMEMS HF System significantly reduced heart failure hospitalization rates by 82% in NYHA Class III patients after one year of haemodynamic-guided management, compared to the year before sensor implantation.

The study demonstrated a high safety profile, with 100% freedom from device-related complications and 99% freedom from pressure sensor failure over two years, indicating that this remote management strategy is both effective and safe for high-risk heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study. Cowie, MR., Flett, A., Cowburn, P., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Current Role of the CardioMEMS Device for Management of Patients with Heart Failure. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Implantable devices for heart failure monitoring: the CardioMEMS™ system. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Large pulmonary artery pseudoaneurysm after CardioMEMS implantation: a case report. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The CardioMEMS Heart Failure System for chronic heart failure - a European perspective. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Understanding adherence to the CardioMEMS pulmonary artery pressure monitoring system for heart failure: A qualitative study. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study. [2022]