CardioMEMS for Heart Failure

(CardioClip Trial)

Overseen By Michael Brener, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Aspirin, Clopidogrel

Disqualifiers: Congenital heart disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves monitoring heart function to adjust medications, it's possible that some changes might be needed. Please discuss this with the trial team for more details.

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

Research shows that the CardioMEMS device can improve quality of life and reduce hospitalizations for people with heart failure by monitoring heart-related pressures remotely. However, there are concerns about its effectiveness in certain patient groups, and more studies are needed, especially in Europe, to confirm its benefits. ^{1 2 3 4 5}

Is the CardioMEMS system safe for use in humans?

The CardioMEMS system is generally considered safe for use in heart failure patients, as noted by the FDA panel in 2011. However, there are potential risks during the sensor placement, such as injury to the pulmonary artery, which can lead to bleeding. ^{2 3 4 6 7}

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

The CardioMEMS treatment is unique because it involves an implantable wireless sensor placed in the pulmonary artery to remotely monitor pressure, allowing for proactive management of heart failure and reducing hospitalizations, unlike traditional treatments that are often reactive. ^{1 2 3 4 8}

What is the purpose of this trial?

The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.

Research Team

Nir Uriel, MD

Principal Investigator

Columbia University

Michael Brener, MD

Principal Investigator

Columbia University

Eligibility Criteria

The CardioClip study is for individuals with heart failure and mitral valve regurgitation. Participants should be suitable for the non-surgical insertion of a wireless sensor through a vein in the groin, similar to mTEER procedure.

Inclusion Criteria

I have moderate to severe secondary mitral regurgitation.

My heart's pumping ability is reduced but not severely impaired.

I experience mild to severe heart symptoms.

Exclusion Criteria

I was born with a complex heart condition.

My heart's left ventricle is not larger than 70 mm when contracted.

My pulmonary artery pressure is 70 mmHg or less.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mitral transcatheter edge-to-edge repair (mTEER) and receive a wireless pulmonary artery pressure sensor

1 week

1 visit (in-person)

Monitoring

Continuous monitoring of heart function using the implanted sensor to optimize medication

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits at 1, 6, and 12 months

Treatment Details

Interventions

• CardioMEMS

Trial Overview This trial tests a wireless sensor called CardioMEMS that monitors pulmonary artery pressure. It's inserted via the groin and sends heart function data so doctors can adjust treatments promptly based on real-time information.

Participant Groups

Group I: CardioMems Experimental Treatment 1 Intervention

Participants randomized to this arm will receive hemodynamic-guided GDMT titration with CardioMems.

Group II: Usual Care Active Control 1 Intervention

Participants randomized to this arm will receive usual care involving GDMT.

CardioMEMS is already approved in United States for the following indications:

Approved in United States as CardioMEMS HF System for:

• Heart failure management in NYHA Class II and III patients

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

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]

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 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 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 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 heart failure system is an FDA-approved device for patients with class III heart failure that enables remote monitoring of pulmonary artery pressures, which can help manage heart failure more effectively.

Understanding the technical aspects of the implantation procedure is crucial for successful use, as the review provides detailed insights into the procedure, imaging requirements, and potential clinical issues through case studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CardioMEMS Heart Failure Sensor: A Procedural Guide for Implanting Physicians. Shavelle, D., Jermyn, R.[2017]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. 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]

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. 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]

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

The CardioMEMS Heart Failure Sensor: A Procedural Guide for Implanting Physicians. [2017]

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

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