Cordella™ Sensor System for Heart Failure

(PROACTIVE-HF Trial)

Recruiting at 92 trial locations

Overseen By Yolanda Murr

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endotronix, Inc.

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

738 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device called the Cordella PA Sensor System, which monitors heart pressure. It is aimed at patients with moderate to severe heart failure who need better treatment options. The device helps doctors track heart function and adjust treatments accordingly. The Cordella PA Sensor System is a novel device for continuous monitoring of heart pressure, similar to the previously approved CardioMEMS device.

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 data supports the effectiveness of the Cordella™ Sensor System for Heart Failure treatment?

Research shows that using the Cordella™ Pulmonary Artery Pressure Sensor for remote monitoring can reduce hospitalizations and deaths in heart failure patients by allowing early detection of worsening conditions and timely medical intervention. ^{1 2 3 4 5}

Is the Cordella Sensor System safe for use in humans?

The Cordella Sensor System has been evaluated for safety in studies, such as the SIRONA trials, which focused on its use in heart failure patients. These studies suggest that the system is generally safe for monitoring pulmonary artery pressure in humans. ^{1 2 4 6 7}

How is the Cordella™ Sensor System treatment different from other heart failure treatments?

The Cordella™ Sensor System is unique because it uses a wireless sensor implanted in the pulmonary artery to remotely monitor pressure changes, allowing for early detection of heart failure worsening and timely treatment adjustments, potentially reducing hospitalizations. ^{1 2 3 8 9}

Research Team

Andrea Sauerland

Principal Investigator

Endotronix, Inc.

Eligibility Criteria

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 am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

References

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

A Procedural Guide for Implanting the Cordella Pulmonary Artery Pressure Sensor. [2023]

2. England 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. [2021]

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

Remote telemonitoring for patients with heart failure: might monitoring pulmonary artery pressure become routine? [2014]

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

Safety and efficacy of a wireless pulmonary artery pressure sensor: primary endpoint results of the SIRONA 2 clinical trial. [2022]

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

The cost-effectiveness of real-time pulmonary artery pressure monitoring in heart failure patients: a European perspective. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Recent Advances in Remote Pulmonary Artery Pressure Monitoring for Patients with Chronic Heart Failure: Current Evidence and Future Perspectives. [2023]

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]

8. England pubmed.ncbi.nlm.nih.gov

CardioMEMSTM System in the Daily Management of Heart Failure: Review of Current Data and Technique of Implantation. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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