Pulmonary Artery Sensor for Heart Failure

Recruiting at 65 trial locations

Overseen By Andrea Sauerland

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endotronix, Inc.

Must be taking: Diuretics, SGLT2i

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Stage D heart failure, Pulmonary embolism, Low blood pressure, 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: 24 months

1750 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data. * Treatment Arm (Group 1) * Active Control Arm (Group 2) * Crossover Arm (Group 3) NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop your current medications. In fact, it requires that you continue appropriate heart failure medications as per guidelines, unless you have specific reasons not to take them.

What data supports the effectiveness of the Cordella Pulmonary Artery Sensor System treatment for heart failure?

Research shows that remote monitoring of pulmonary artery pressure using the Cordella system can reduce hospitalizations and improve outcomes for heart failure patients by allowing early adjustments in medical therapy. ^{1 2 3 4 5}

Is the Cordella Pulmonary Artery Sensor System safe for humans?

The Cordella Pulmonary Artery Sensor System has been evaluated for safety in studies, such as the SIRONA first-in-human study, which investigated its safety and accuracy. These studies suggest that the system is generally safe for use in humans, particularly for monitoring heart failure. ^{1 3 5 6 7}

How does the Cordella Pulmonary Artery Sensor treatment differ from other heart failure treatments?

The Cordella Pulmonary Artery Sensor is unique because it is a wireless device implanted in the pulmonary artery to remotely monitor pressure, allowing for proactive management of heart failure. This differs from traditional treatments that do not provide continuous, real-time data to help prevent hospitalizations. ^{1 4 5 8 9}

Research Team

Andrea Sauerland

Principal Investigator

Endotronix, Inc.

Eligibility Criteria

This trial is for adults with heart failure who've been treated for at least 3 months and are in NYHA Class II or III. They should be on stable heart failure medication as per guidelines, though exceptions can be made if they're intolerant or cannot afford these medications. Recent hospitalization for heart failure and certain levels of NT-proBNP (a heart stress marker) are also required.

Inclusion Criteria

I have heart failure with reduced ejection fraction and have been on stable heart medications for at least 30 days.

I have been on stable heart failure medication as per guidelines for over 30 days.

I have heart failure with preserved ejection fraction and have been on stable SGLT2 inhibitors for at least 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Cordella PA Sensor System and are managed according to Guideline-Directed Medical Therapy

24 months

Regular monitoring visits

Crossover

Participants in the Active Control Arm can qualify to crossover to the Crossover Arm after 12 months and an adjudicated HFH

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Cordella™ Pulmonary Artery Sensor System

Trial Overview The PROACTIVE-HF-2 Trial is testing the Cordella™ Pulmonary Artery Sensor System's safety and effectiveness in patients with different severities of heart failure. It includes five groups: some getting the device, others serving as controls, and a group that switches from control to treatment.

Participant Groups

Group I: NYHA III Phase I Treatment Arm Experimental Treatment 1 Intervention

All subjects will receive the Cordella Sensor. Clinicians will manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.

Group II: NYHA III Phase I Active Control Arm Experimental Treatment 1 Intervention

All subjects will receive the Cordella Sensor. Clinicians will manage subjects using the subjects daily data trends (BP, weight, HR, SpO2 symptoms) according to Guideline Directed Medical Therapy. Once the primary endpoint (6 months) is met, subjects and clinicians will be unblinded to PAP.

Group III: NYHA III Clinician-Directed Patient Self-Management Arm (randomized) Experimental Treatment 1 Intervention

This is Phase II / Randomization #2 following implant provided patient meets eligiibity criteria. Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will oversee the patient self-management to target PAP per protocol specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.

Group IV: NYHA III Clinician Management Arm (randomized) Experimental Treatment 1 Intervention

This is Phase II / Randomization #2 following implant provided patient meets eligiibity criteria. Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will manage the patients to target PAP per protocols specific to Treatment Guidelines and according to Guideline Directed Medical Therapy.

Group V: NYHA III Clinician Management Arm (Not randomized) Experimental Treatment 1 Intervention

Subject will not be randomized if they do not meet eligibility criteria to potentially be randomized to Clinician-Directed Patient Self-Management. Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will manage the patients to target PAP per protocols specific to Treatment Guidelines and according to Guideline Directed Medical Therapy.

Group VI: NYHA II Treatment Arm Experimental Treatment 1 Intervention

All subjects will receive the Cordella Sensor. Clinicians will manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.

Group VII: NYHA II Crossover Arm Experimental Treatment 1 Intervention

All subjects will receive the Cordella Sensor. At least 12 months following implant and following an adjudicated HFH, subjects in the Active Control Arm can qualify to crossover to the Crossover Arm and both patients and clinicians would then be unmasked to PAP. Clinicians will then manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.

Group VIII: NYHA II Active Control Arm Experimental Treatment 1 Intervention

All subjects will receive the Cordella Sensor. Clinicians will manage subjects using the subjects daily data trends (BP, weight, HR, SpO2 symptoms) according to Guideline Directed Medical Therapy. Once the primary endpoint (24 months) is met, subjects and clinicians will be unblinded to PAP.

Who Is Running the Clinical Trial?

Endotronix, Inc.

Lead Sponsor

Trials

6

Recruited

4,700+

Findings from Research

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]

A new system for measuring and recording ambulatory pulmonary artery pressure has been successfully developed and tested in 18 patients, demonstrating technical success in 14 of those cases.

This innovative system allows for continuous monitoring and analysis of pulmonary artery pressure, which could enhance our understanding of heart and lung diseases in real-life settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new system for ambulatory pulmonary artery pressure recording. Gibbs, JS., MacLachlan, D., Fox, KM.[2019]

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]

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 Heart Failure Sensor (HFS) accurately measures pulmonary artery pressure (PAP) in ambulatory heart failure patients, showing a strong correlation with traditional Swan-Ganz catheterization and echocardiography methods, with a mean difference of only 6.2 mm Hg for systolic PAP.

In a study involving 12 heart failure patients, the HFS demonstrated reliable performance over a 90-day period, indicating its potential as a valuable tool for monitoring and managing heart failure without the need for invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a radiofrequency-based wireless pressure sensor to swan-ganz catheter and echocardiography for ambulatory assessment of pulmonary artery pressure in heart failure. Verdejo, HE., Castro, PF., Concepción, R., et al.[2022]

A new implantable pulmonary arterial device was successfully tested in 10 sheep, showing excellent correlation with conventional pressure measurement methods, indicating its potential for accurate long-term hemodynamic monitoring.

The implantation of the device was safe and uneventful, with over 18,500 measurements taken, suggesting that this technology could be a reliable option for continuous monitoring of pulmonary artery pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemetric catheter-based pressure sensor for hemodynamic monitoring: experimental experience. Mahnken, AH., Urban, U., Fassbender, H., et al.[2009]

In a study of 1200 patients with Class III heart failure, the use of an implantable pulmonary artery sensor significantly reduced hospitalizations for heart failure, with a decrease from 1.25 to 0.54 events per patient-year after sensor implantation.

The safety profile was excellent, with 99.6% of patients free from device-related complications and 99.9% free from sensor failure at one year, indicating that this therapy is both effective and safe for a diverse patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study. Shavelle, DM., Desai, AS., Abraham, WT., et al.[2021]

References

1. 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]

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

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

3. 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]

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

A new system for ambulatory pulmonary artery pressure recording. [2019]

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

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

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

Comparison of a radiofrequency-based wireless pressure sensor to swan-ganz catheter and echocardiography for ambulatory assessment of pulmonary artery pressure in heart failure. [2022]

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

Telemetric catheter-based pressure sensor for hemodynamic monitoring: experimental experience. [2009]

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

Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study. [2021]