Aortix Device for Heart Failure

(DRAIN-HF Trial)

Recruiting at 49 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

Trial Summary

What is the purpose of this trial?

This trial tests a device called Aortix that helps the heart pump blood better. It targets patients with severe heart failure who don't get better with usual treatments. The device works by helping the heart move blood more efficiently.

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 data supports the effectiveness of the Aortix Device treatment for heart failure?

Research on continuous aortic flow augmentation, similar to the Aortix Device, shows it can improve heart function and reduce stress on the heart in animal models of heart failure, suggesting it might help patients whose heart failure isn't responding well to other treatments. ^{1 2 3 4 5}

How is the Aortix Device treatment for heart failure different from other treatments?

The Aortix Device is unique because it is an endovascular (inside the blood vessel) device designed to support heart function by improving blood flow, unlike traditional treatments like ventricular assist devices (VADs) that require more invasive surgical implantation. ^{4 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England 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. [2020]

3. United States 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. [2016]

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

Experience with over 1000 implanted ventricular assist devices. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Aortic valve disorders and left ventricular assist devices. [2023]

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

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement. [2020]

7. Ireland pubmed.ncbi.nlm.nih.gov

Predictors of in-hospital mortality in patients with left ventricular assist device. [2020]

8. Chile pubmed.ncbi.nlm.nih.gov

[Left ventricular assistant devices for end-stage heart failure: report of two cases]. [2022]

9. Netherlands 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. [2021]