What side effects are associated with this type of intervention?

Common treatments for heart failure that involve monitoring pulmonary artery pressure, such as the Cordella PA Sensor System, often include the use of medications like diuretics, ACE inhibitors, beta-blockers, and aldosterone antagonists. Known side effects of these treatments can include electrolyte imbalances, kidney dysfunction, hypotension, dizziness, and increased risk of infection. Additionally, invasive monitoring systems may pose risks such as infection, bleeding, and device-related complications.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that involve monitoring and managing pulmonary artery pressure. One notable example is the CardioMEMS HF System, which is an implantable device that measures pulmonary artery pressure and transmits the data to healthcare providers to guide treatment. This system helps in adjusting medications and other therapies to manage heart failure more effectively. Additionally, various drugs such as beta-blockers, ACE inhibitors, and diuretics are commonly used in heart failure management to improve symptoms and reduce hospitalizations.

What other types of research exist?

Promising novel alternatives to the Cordella PA Sensor System for heart failure management in 2024 include: 1) The CardioMEMS HF System, which also monitors pulmonary artery pressure and has shown to reduce heart failure hospitalizations. 2) The Barostim Neo System, a neuromodulation device that improves heart function by stimulating the baroreceptors. 3) Wearable biosensors and remote monitoring platforms that provide continuous data on vital signs and heart function, enabling proactive management of heart failure. These alternatives offer innovative approaches to monitoring and managing heart failure, potentially improving patient outcomes.

← Back to Search

Device

Cordella™ Sensor System for Heart Failure (PROACTIVE-HF Trial)

N/A

Waitlist Available

Research Sponsored by Endotronix, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader

Subjects should be on diuretic therapy

Must not have

Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit

Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from using the device daily and risks associated with any invasive procedure like infection or bleeding since it involves implantation of a sensor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am currently taking water pills.

Select...

I have been hospitalized or needed urgent care for heart failure in the last year.

Select...

I can see, hear, and understand well enough to use a medical device.

Select...

I have been diagnosed and treated for heart failure for at least 3 months and am currently experiencing moderate heart failure symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I am allergic to common blood thinners like aspirin.

Select...

I cannot tolerate certain heart medications due to low blood pressure or kidney issues.

Select...

I have a serious heart valve problem that hasn't been fixed.

Select...

I have advanced heart failure and may be on medication to help my heart pump.

Select...

I do not have a severe illness limiting my life expectancy to less than a year.

Select...

I am willing and able to follow the study's requirements.

Select...

I have a known blood clotting disorder.

Select...

My kidney function is very low or I am on long-term dialysis.

Select...

I have had 2 or more lung clots or a recent deep vein clot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hyalinosis, Systemic

Safety: Freedom from device/system related complication

Safety: Freedom from pressure sensor failure

Secondary study objectives

Days Alive and Out of Hospital (DAOH)

Device success

Perinatal death

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 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).

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include diuretics, which reduce fluid overload and decrease pulmonary congestion; ACE inhibitors and ARBs, which lower blood pressure and reduce the heart's workload by inhibiting the renin-angiotensin-aldosterone system; beta-blockers, which slow the heart rate and decrease myocardial oxygen demand; and devices like the Cordella PA Sensor System, which monitor pulmonary artery pressure to guide therapy and prevent decompensation. These treatments are crucial as they help manage symptoms, improve quality of life, and reduce hospitalizations for heart failure patients.

Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction.[Treatment of heart failure due to systolic dysfunction].