Cordella™ Sensor System for Heart Failure

(PROACTIVE-HF Trial)

Not currently recruiting at 92 trial locations

Overseen By Yolanda Murr

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endotronix, Inc.

Must be taking: Diuretics

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Stage D heart failure, 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: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of the Cordella™ Sensor System for individuals with a specific type of heart failure. It targets those who have lived with heart failure for at least three months and face daily challenges, such as frequent hospital visits for treatment. Participants will use a device that monitors heart health by tracking certain vital signs daily. This study suits those who can manage the device and have experienced heart failure-related hospital visits or treatments in the past year. As an unphased trial, it offers participants the chance to contribute to important research that could enhance heart failure management.

Will I have to stop taking my current medications?

The trial requires participants to be on stable, optimally titrated heart failure medication for at least 30 days before joining. This means you should continue your current medications as prescribed.

What prior data suggests that the Cordella™ Sensor System is safe for heart failure patients?

Research has shown that the Cordella Pulmonary Artery Sensor System is generally safe for people with heart failure. In a study with 456 patients, those using the Cordella system had fewer hospital visits for heart failure over a year, suggesting it is safe and may help manage heart conditions effectively.

Other studies have also found that this system improves patients' quality of life while reducing heart-related hospital stays. These findings indicate that the Cordella system is a safe option for monitoring and managing heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cordella™ Pulmonary Artery Sensor System because it offers a novel approach to managing heart failure by continuously monitoring pulmonary artery pressure. Unlike traditional treatments that rely on periodic clinical visits to evaluate heart failure status, this system allows for real-time, daily data collection on vital signs and pulmonary artery pressure. This continuous monitoring can lead to more personalized and timely adjustments in heart failure management, potentially improving patient outcomes and reducing hospitalizations.

What evidence suggests that the Cordella™ Sensor System is effective for heart failure?

Research has shown that the Cordella Pulmonary Artery Sensor System, used by participants in this trial, can help manage heart failure. Studies have found that tracking lung blood pressure with this system significantly reduces hospital visits for heart failure over a year. In one study, patients experienced fewer hospital visits and improved overall health. This sensor system enables doctors to monitor heart pressure changes more closely, which is crucial for managing the condition. Evidence suggests that this tool can greatly enhance the lives of people with heart failure. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrea Sauerland

Principal Investigator

Endotronix, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with NYHA Class III Heart Failure who've been on stable heart failure therapy for at least 30 days and have had a recent hospital visit or high NT-proBNP levels. They must be able to use the myCordella™ Patient Reader device daily, have good internet at home, and commit to follow-up visits. Excluded are those with severe kidney issues, non-compliance history, certain cardiovascular events within 3 months, specific intolerances or allergies, active infections, pregnancy/breastfeeding, or other life-limiting severe illnesses.

Inclusion Criteria

I can hold a 1.3lb device against my chest for 2 minutes daily and dock it.

I have been on a stable heart failure treatment for at least 30 days.

I am currently taking water pills.

Exclusion Criteria

Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study

I have not had a major heart event like a heart attack or stroke in the last 3 months.

I am likely to get an advanced therapy like a heart or lung transplant soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Cordella PA Sensor System for heart failure management, with daily monitoring of pulmonary artery pressure and vital signs

6 months

Regular monitoring visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of heart failure hospitalizations and mortality

6 months

Extension

Participants may continue to be monitored for long-term outcomes such as heart failure hospitalizations and mortality

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cordella™ Pulmonary Artery Sensor System

Trial Overview The Cordella PA Sensor System is being tested in this study. It's an open-label trial where all participants receive the sensor system designed to monitor their heart failure status compared against a performance goal set by previous data.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) and Guideline Directed Medical Therapy (GDMT) considering daily Pulmonary Artery Pressure (PAP) measurements and vital signs collected by Cordella Heart Failure System (CHFS).

Cordella™ Pulmonary Artery Sensor System is already approved in United States, European Union for the following indications:

Approved in United States as Cordella PA Sensor System for:

• NYHA Class III heart failure

Approved in European Union as Cordella PA Sensor System for:

• Investigational use only; awaiting CE Mark approval

Who Is Running the Clinical Trial?

Endotronix, Inc.

Lead Sponsor

Trials

6

Recruited

4,700+

Published Research Related to This Trial

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 Cordella pulmonary artery pressure sensor is a wireless device designed for remote monitoring of pulmonary artery pressures, which can enhance patient management in heart conditions.

Successful implantation of the sensor requires understanding specific technical details, as demonstrated through a series of cases in the U.S. and Europe, highlighting its potential for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Procedural Guide for Implanting the Cordella Pulmonary Artery Pressure Sensor. Guichard, JL., Sharif, F., Forouzan, O., et al.[2023]

Heart failure is a growing medical issue, and frequent self-monitoring of patients' clinical and physiological variables at home could help stabilize their condition and reduce hospitalizations.

Remote monitoring of pulmonary artery pressure using percutaneously implanted devices may provide an early warning for cardiac decompensation, allowing for timely adjustments in treatment and potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote telemonitoring for patients with heart failure: might monitoring pulmonary artery pressure become routine? Hutchinson, K., Pellicori, P., Dierckx, R., et al.[2014]

Remote monitoring of pulmonary artery pressures (PAP) has proven to be the most effective method for early detection of worsening chronic heart failure (HF), potentially reducing hospital admissions.

Current systems like CardioMEMS and Cordella HF are leading the way in this technology, with ongoing studies aimed at enhancing the evidence base, particularly in Europe, to improve HF management globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances in Remote Pulmonary Artery Pressure Monitoring for Patients with Chronic Heart Failure: Current Evidence and Future Perspectives. Clephas, PRD., Aydin, D., Radhoe, SP., 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 Cordella™ Pulmonary Artery Pressure Sensor was safely implanted in 15 patients with heart failure, with no device-related complications reported, indicating a strong safety profile for this new monitoring technology.

The sensor demonstrated accurate measurements of pulmonary artery pressure, with results closely aligning with traditional methods, and showed high patient adherence to daily monitoring, suggesting it could effectively support heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the SIRONA first-in-human study. Mullens, W., Sharif, F., Dupont, M., et al.[2021]

The CardioMEMSTM HF system is a wireless monitoring tool that tracks pulmonary artery pressure, allowing healthcare providers to detect early signs of heart failure decompensation and adjust treatments promptly, which can help prevent rehospitalization.

Data from trials and registries indicate that using the CardioMEMSTM system is associated with reduced heart failure hospitalization rates and improved quality of life, making it a safe and cost-effective option for managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CardioMEMSTM System in the Daily Management of Heart Failure: Review of Current Data and Technique of Implantation. Mangi, MA., Nesheiwat, Z., Kahloon, R., et al.[2022]

The Cordella™ PA Sensor System was successfully implanted in 70 patients with NYHA Class III heart failure, showing excellent accuracy in measuring pulmonary artery pressures compared to standard right heart catheterization, with a mean difference well within acceptable limits.

The device demonstrated a high safety profile, with 98.6% of patients free from device-related complications within 30 days post-implant, and a strong adherence rate of 94% for daily monitoring of pulmonary artery pressures and vital signs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a wireless pulmonary artery pressure sensor: primary endpoint results of the SIRONA 2 clinical trial. Sharif, F., Rosenkranz, S., Bartunek, J., et al.[2022]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jchf.2024.05.017

Results of the PROACTIVE-HF Trial - Heart Failure The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230040B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Cordella Pulmonary Artery Sensor System is intended to measure, record and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure ...

3. prnewswire.com prnewswire.com/news-releases/one-year-data-show-excellent-outcomes-for-endotronix-cordella-pulmonary-artery-sensor-system-302261725.html

ONE-YEAR DATA SHOW EXCELLENT OUTCOMES FOR ... The data demonstrated that the 456 patients managed with Cordella in the study experienced a meaningful reduction in one-year HF hospitalization and all-cause ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05934487

PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9715805/

Safety and efficacy of a wireless pulmonary artery pressure ... Implantable pulmonary artery pressure (PAP) sensors have been shown to reduce heart failure hospitalizations (HFH) in selected patients.

6. endotronix.com endotronix.com/hemodynamic-monitoring/

Cordella: Streamlined remote PA pressure monitoring PA pressure-guided therapy with Cordella has been shown to improve patient quality of life and have low HF hospitalization rates.