Aortix Device for Heart Failure

(DRAIN-HF Trial)

Recruiting at 47 trial locations

Overseen By Elaine Karaelias

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Procyrion

Must be taking: IV diuretics

Must not be taking: Vasopressors, Inotropes

Disqualifiers: Kidney failure, Cirrhosis, Infection, 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: 1

Duration: 7 days

295 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device called Aortix for individuals with chronic heart failure who have experienced a sudden worsening of their condition requiring hospitalization. The study will compare the Aortix device to standard medical care to determine which method better manages fluid buildup. Patients currently hospitalized with heart failure who have not responded well to diuretics may be suitable candidates. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options that could enhance their quality of life.

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

The trial information does not specify if you need to stop your current medications. However, it mentions that patients should not have been treated with certain high-dose medications or vasopressors within 48 hours before enrollment. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Aortix device is safe for heart failure patients?

Research has shown that the Aortix device appears safe for patients with heart failure. In studies involving patients with sudden worsening of heart failure and ongoing fluid buildup, the Aortix device presented no major safety issues. These studies suggest that the device can help reduce fluid buildup, a common problem in heart failure, without causing significant harm.

Patients in these studies handled the Aortix device well, with no reports of serious side effects directly linked to it. While mild side effects might occur, the device itself seems safe for use under the studied conditions. This is important for those who have not responded well to standard treatments.

Overall, previous research supports the Aortix device as a safe option for people with difficult-to-treat heart failure. As with any medical treatment, discussing potential risks and benefits with a healthcare provider is crucial before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Aortix device for heart failure because it offers a new approach to managing this challenging condition. Unlike traditional treatments that primarily rely on medications like diuretics to manage symptoms, the Aortix device mechanically supports the heart by improving blood flow and reducing the heart's workload. This unique method could potentially help patients with diuretic resistance, offering an alternative when standard medications are less effective. By directly targeting hemodynamic support, the Aortix device may provide quicker relief and improved outcomes for patients struggling with advanced heart failure.

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

Research has shown that the Aortix device, which participants in this trial may receive, may assist patients experiencing sudden worsening of heart failure and those unresponsive to water pills. A small study found that patients using Aortix safely eliminated excess fluid, even when kidney function was declining. Removing excess fluid is crucial for heart failure patients. Another study compared the Aortix device to regular treatment and found it safe and effective. These findings suggest that Aortix could benefit patients struggling with standard treatments. In this trial, eligible patients will be randomized to receive either the Aortix system or standard medical management. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for hospital-admitted adults over 21 with acute decompensated heart failure who haven't responded well to at least 48 hours of high-dose diuretics. They should have symptoms like swelling or fluid buildup despite treatment, and women must not be pregnant.

Inclusion Criteria

My urine output was less than 1500 ml in the last 12 hours despite taking high doses of water pills.

I am over 21 years old and can sign a consent form.

I still have swelling or fluid in my abdomen despite treatment with strong water pills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Aortix system or standard of care medical management

7 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person) at 30 days

Advanced HF Registry

Eligible subjects receive Aortix system support to improve renal function for advanced therapies

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Device

Trial Overview The study compares the Aortix circulatory support device against standard medical management in patients with chronic heart failure hospitalized for acute episodes and resistant to diuretic therapy. Participants are randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management. Randomization will be stratified by ejection fraction.

Group II: Advanced HF Registry Experimental Treatment 1 Intervention

For the Advanced HF registry, all eligible enrolled subjects will receive Aortix system support.

Group III: Control Arm Active Control 1 Intervention

The Control arm should receive standard of care therapy as per the study directed Diuretic Care Treatment Algorithm.

Device is already approved in United States for the following indications:

Approved in United States as Aortix System for:

• None - Investigational use only

Who Is Running the Clinical Trial?

Procyrion

Lead Sponsor

Trials

3

Recruited

340+

Published Research Related to This Trial

The study of 2,359 patients with left ventricular assist devices (LVADs) from 2010 to 2014 found that in-hospital mortality rates did not improve during this period, indicating that continuous flow (CF)-LVADs have not reduced mortality rates for patients with end-stage heart failure.

Significant predictors of in-hospital mortality included comorbidities such as hemodialysis, cerebrovascular disease, and complications like sepsis and gastrointestinal bleeding, suggesting that patient selection and management of comorbid conditions are critical for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of in-hospital mortality in patients with left ventricular assist device. Gonuguntla, K., Patil, S., Cowden, RG., et al.[2020]

The case study highlights the successful use of a left ventricular assist device (LVAD) as a routine therapy for a 74-year-old male patient with advanced heart failure due to dilated cardiomyopathy.

The patient underwent LVAD implantation along with simultaneous aortic valve replacement and ascending aortic replacement, demonstrating the feasibility of combining these procedures in complex cases of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement. Huenges, K., Panholzer, B., Cremer, J., et al.[2020]

Left ventricular devices have emerged as a promising alternative for patients with end-stage heart failure who are awaiting cardiac transplantation, as they can improve heart function and increase blood flow.

The successful implantation of these devices using a minimally invasive technique in two patients at our hospital demonstrates the potential for this approach to help severely ill patients while they wait for a donor heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Left ventricular assistant devices for end-stage heart failure: report of two cases]. Pedemonte, O., Vera, A., Schmitto, JD., et al.[2022]

Heart failure (HF) negatively impacts blood flow dynamics by decreasing wall shear stress (WSS) and weakening helical flow strength, which can lead to adverse hemodynamic conditions.

Pulsatile flow ventricular assist devices (VADs) improve WSS and induce helical flow, suggesting they may be more beneficial for heart failure patients compared to continuous flow VADs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic effects of the human aorta arch with different inflow rate waveforms from the ascending aorta inlet: A numerical study. Chen, Y., Yang, Y., Tan, W., et al.[2021]

Between 1987 and 2006, 1026 ventricular assist devices (VADs) were implanted in 970 patients, showing improved survival rates, especially in those with preoperative end-stage heart failure, as opposed to those with postcardiotomy heart failure who had higher early mortality rates (50.9%).

VAD implantation can lead to recovery from secondary organ failure, and patients should be considered for VADs before reaching profound cardiogenic shock, as this may enhance their chances of survival and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with over 1000 implanted ventricular assist devices. Potapov, EV., Loforte, A., Weng, Y., et al.[2022]

In a study of 237 patients with HeartMate II continuous-flow left ventricular assist devices (CF-LVADs), moderate or severe aortic insufficiency (AI) developed in 15.2% of patients, with the risk increasing over time, particularly in older patients and females.

Despite the occurrence of moderate or severe AI, there was no significant impact on long-term survival rates, with overall survival at 1, 3, and 5 years being 78%, 59%, and 42%, respectively, indicating that while AI is a concern, it does not affect mortality in CF-LVAD recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aortic insufficiency in continuous-flow left ventricular assist device support patients is common but does not impact long-term mortality. Holley, CT., Fitzpatrick, M., Roy, SS., et al.[2022]

In a review of eight studies involving 6416 advanced heart failure patients with continuous-flow left ventricular assist devices (CF-LVADs), implantable cardioverter-defibrillator (ICD) implantation did not show a significant difference in all-cause mortality compared to patients without ICDs (HR 0.96).

The study also found no significant difference in the likelihood of heart transplantation or non-mortality adverse events between the ICD and no ICD groups, indicating that ICDs may not provide the expected survival benefits in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable cardioverter-defibrillators and survival in advanced heart failure patients with continuous-flow left ventricular assist devices: a systematic review and meta-analysis. Elkaryoni, A., Badarin, FA., Khan, MS., et al.[2020]

Continuous aortic flow augmentation (CAFA) significantly improved hemodynamics in 24 patients with heart failure exacerbation, showing reductions in systemic vascular resistance and pulmonary capillary wedge pressure within 72 hours of treatment.

CAFA also trended towards improved kidney function, as indicated by a decrease in serum creatinine levels, suggesting it may be a promising treatment for patients not responding adequately to standard medical therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous aortic flow augmentation: a pilot study of hemodynamic and renal responses to a novel percutaneous intervention in decompensated heart failure. Konstam, MA., Czerska, B., Böhm, M., et al.[2016]

Aortic insufficiency (AI) can worsen the effectiveness of left ventricular assist devices (LVAD) and is linked to increased hospitalizations and decreased survival rates in patients, highlighting the importance of monitoring and managing this condition in advanced heart failure.

Management strategies for AI include surgical repair or replacement during LVAD implantation for pre-existing cases, while de novo AI during LVAD support may require innovative approaches like transcatheter aortic valve replacement due to the risks associated with repeat surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aortic valve disorders and left ventricular assist devices. Acharya, D., Kazui, T., Al Rameni, D., et al.[2023]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jchf.2023.06.018

Safety and Performance of the Aortix Device in Acute ... This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05677100

Diuretics Alone vs. Aortix Endovascular Device for Acute ... The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37804307/

Safety and Performance of the Aortix Device in ... - PubMed This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion ...

4. procyrion.com procyrion.com/overview

PROCYRION AORTIX TM Overview •Acute decompensated heart failure with diuretic resistance •Renal support to reduce acute kidney injury in cardiac surgery and coronary interventions

5. procyrion.com procyrion.com/news/procyrion-announces-first-patient-enrollments-in-the-drain-hf-pivotal-trial

Procyrion Announces First Patient Enrollments in the ... The DRAIN-HF pivotal trial (NCT05677100) is evaluating the safety and effectiveness of the Aortix pump compared to standard of care medical therapy.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04145635

Study Details | NCT04145635 | The Aortix CRS Pilot Study The study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and performance of the Aortix System in patients ...

7. procyrion.com procyrion.com/

Procyrion™ | Aortix™ Aortix is a percutaneous mechanical circulatory support (pMCS) device designed to treat heart failure patients who are too sick for medication alone.