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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wireless sensor, CardioMEMS, which monitors pressure in the lungs' main artery. The goal is to determine if this sensor can help doctors adjust heart failure treatments by providing real-time information, potentially improving patient outcomes. Participants will either receive treatment based on the sensor's readings or follow usual care routines. The trial seeks individuals with moderate to severe heart valve issues and symptoms affecting daily life, such as breathlessness during normal activities. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance heart failure management.

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 prior data suggests that this wireless sensor is safe for monitoring pulmonary artery pressure?

Research has shown that the CardioMEMS system is generally safe for people. One study found that the CardioMEMS device did not cause any serious device-related problems for up to 24 months after implantation. Another study reported no serious device-related issues after two years and almost no sensor failures. This evidence suggests that the device is well-tolerated and reliable over time.

Overall, these findings indicate that the CardioMEMS system is safe for monitoring patients with heart failure, making it a promising tool for helping doctors manage heart conditions more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CardioMEMS for heart failure because it offers a novel way to monitor patients. Unlike standard treatments that primarily focus on medications like ACE inhibitors, beta-blockers, or diuretics, CardioMEMS uses a small implantable device to continuously measure pulmonary artery pressure. This real-time data allows for more precise and timely adjustments in treatment, potentially improving patient outcomes by preventing hospitalizations. The ability to guide therapy based on direct hemodynamic measurements is a game-changer for managing heart failure more effectively.

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

Research has shown that the CardioMEMS system can greatly help people with heart failure. In this trial, participants in the CardioMEMS arm will receive hemodynamic-guided GDMT titration using the CardioMEMS system. Studies have found that patients using this system had 36% fewer hospital visits for heart failure within a year. Another study showed a 46% drop in hospital visits after just six months. The device also helps patients live longer, offering hope for better long-term health. These findings suggest that using the CardioMEMS sensor to monitor heart pressure can be very beneficial, as it allows doctors to adjust treatments quickly. ^{1 2 4 5 6}

Who Is on the Research Team?

Nir Uriel, MD

Principal Investigator

Columbia University

Michael Brener, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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 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 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 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, 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]

Citations

1. 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 ...

2. 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- ...

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 ...