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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing heart failure at home. It uses the CardioMEMS HF System, a device that tracks changes in lung pressure to predict and prevent serious heart problems. The trial aims to determine if this approach can reduce hospital visits and improve overall heart health compared to usual care. Individuals with heart failure who have had at least one hospital visit in the past year and are comfortable using a smartphone or tablet may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative heart failure management research.

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 prior data suggests that the CardioMEMS device is safe for heart failure patients?

Research has shown that the CardioMEMS system is safe for patients. In one study, no serious device-related problems were reported for up to two years after implantation. Another study found that the pressure sensor functioned correctly 99.7% of the time over the same period. These studies indicate that the device is well-tolerated and reliable. It has also been shown to reduce hospital visits for heart failure by up to 44%, resulting in fewer emergency trips for patients. Overall, the CardioMEMS system has a strong record of safety and effectiveness in managing heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CardioMEMS for heart failure because it offers a unique approach to monitoring patients. Unlike traditional treatments that rely on periodic clinic visits to assess heart function, CardioMEMS uses a tiny sensor implanted in the pulmonary artery to provide continuous, real-time data on a patient's heart pressure. This allows for remote monitoring and more timely adjustments to treatment, potentially reducing the risk of hospitalizations and improving quality of life. The ability to have consistent, detailed insights into heart health is a game changer for managing heart failure more proactively.

What evidence suggests that the CardioMEMS HF System is effective for heart failure?

Research shows that the CardioMEMS HF System effectively manages heart failure. In this trial, participants in the treatment arm will receive a CardioMEMS HF sensor and be managed through remote access to hemodynamics. Studies have found that the system can reduce hospital visits for heart failure by 36% after one year and by 46% in some patients after six months. Patients with reduced ejection fraction, a specific type of heart failure, also lived longer over a two-year period. The system is generally safe, with few device-related problems. This evidence suggests that CardioMEMS can improve heart failure care and patient outcomes. ^{1 2 4 5 6}

Who Is on the Research Team?

Anique Ducharme

Principal Investigator

Montreal Heart Institute

Jean Rouleau, MD

Principal Investigator

Montreal Heart Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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 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]

Citations

1. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/heart-failure/pulmonary-pressure-monitors/cardiomems/clinical-evidence.html

CardioMEMS HF System Clinical Evidence Significantly improved survival over control in HFrEF patients at 24 months · 36% decrease in heart failure hospitalizations at 12 months · First ever meta- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11843804/

CardioMEMS Heart Failure System: An Up-to-Date Review Notably, randomized data demonstrate significant benefits specifically in adults with heart failure (HF) symptoms corresponding to New York ...

3. innovationsincrm.com innovationsincrm.com/latest-news/998-cardiomems-hf-system

Late-Breaking Data Shows the CardioMEMS HF System is ... Researchers found a 46 percent reduction in heart failure hospitalizations in patients six months after receiving the CardioMEMS HF System, and a 34 percent ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1875213624003097

Results from the CardioMEMS HF System Post-Market ... The primary efficacy endpoint was evaluated comparing the rate of heart failure hospitalization during the year before and the year after implantation. Results.

5. academic.oup.com academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.1029/7835402

results of the CardioMEMS HF System OUS Post-Market Study After 2 years follow-up there was 100% freedom from DSRCs and 99.7% freedom from pressure sensor failure. The annualized HFH rate after 1 year ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100045S056B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The CardioMEMS™ HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures ...