RV Management After LVAD Implantation for Heart Failure

Overseen By Anthony J Kanelidis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: RV support, Pacemaker-dependent, Pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the best care for the right side of the heart (right ventricle or RV) after implanting a left ventricular assist device (LVAD) to support the left side. It compares two RV management methods: one uses a standardized approach with specific guidelines (Standardized RV Management), and the other relies on doctors' usual care based on their judgment (Usual Care RV Management). Candidates include those who have had an LVAD implanted and do not require additional right-side heart support. The trial aims to identify the most effective way to protect and manage the RV after LVAD surgery. As an unphased trial, it offers a unique opportunity to enhance understanding of optimal care strategies for patients with LVADs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these RV management strategies are safe after LVAD implantation?

Research has shown that 20-40% of patients may experience right ventricular failure (RVF) after receiving a Left Ventricular Assist Device (LVAD), a heart pump that supports the left side of the heart. Although this risk is known, treatments have improved. Studies indicate that recent methods for LVAD implantation have enhanced patient outcomes.

This trial examines two approaches to caring for the right side of the heart after LVAD surgery. In one approach, doctors follow specific guidelines to protect the right side of the heart. In the other, they rely on their clinical judgment. Both methods align with standard care practices. No new drug or device is being tested, so the safety concerns remain similar to those in usual care after LVAD surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing right ventricular (RV) function after a left ventricular assist device (LVAD) implantation in heart failure patients. Unlike usual care, which relies on physicians' clinical judgment without set goals, the standardized RV management method uses specific guidelines to manage RV function. This structured approach aims to improve patient outcomes by ensuring consistent and targeted care, potentially leading to better heart function and overall health for patients with heart failure.

What evidence suggests that this trial's treatments could be effective for RV management after LVAD implantation?

Research has shown that caring for the right side of the heart is crucial after using a device that assists the left side in pumping blood for heart failure patients. Up to 40% of patients may experience right-side heart issues after receiving this device. This trial will compare two approaches: Standardized RV Management, where physicians adhere to prespecified parameters for right-side heart care, and Usual Care RV Management, where physicians rely on their clinical judgment without specific guidelines. Studies have found that careful management of the right side of the heart can lead to better results and fewer complications. Specifically, following specific guidelines for this care can reduce the risk of right-side heart failure. This approach helps maintain heart function and can lead to better patient outcomes compared to usual care. ^{2 6 7 8 9}

Who Is on the Research Team?

Jonathan Grinstein, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are getting a durable LVAD implant to help their heart pump blood, without needing extra mechanical support for the right side of their heart. It's not for pregnant individuals or those with certain devices already in their heart that they depend on.

Inclusion Criteria

I am getting a long-term left ventricular assist device without support for the right side of my heart.

Exclusion Criteria

Pregnant patients

You have a high chance of needing a special heart pump before surgery.

You have a pacemaker and rely on it to help your heart beat regularly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo LVAD implantation and are randomized to either standardized or usual care RV management

10 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hemodynamic monitoring and assessment of RV function

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Standardized RV Management
• Usual Care RV Management

Trial Overview The study is looking at two ways to manage the health of the right ventricle (RV) after an LVAD device has been implanted. One group will receive usual care, while another will follow a standardized RV management plan.

How Is the Trial Designed?

Group I: Usual Care RV Management Active Control 1 Intervention

Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)

Group II: Standardized RV Management Active Control 1 Intervention

Physicians will follow prespecified parameters for RV management (consistent with SOC)

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7947472/

Right ventricular failure after left ventricular assist device ... Although preoperative risks factors can be associated with RV impairment, the physiologic changes after the LV support, can still hamper the function of the RV.

2. jhltopen.org jhltopen.org/article/S2950-1334(25)00053-9/fulltext

Outcomes following isolated right ventricular assist device ... This study compares the clinical characteristics and outcomes of iRVAD patients to those patients treated with left ventricular assist device ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0735109722001711

Trends and Outcomes of Left Ventricular Assist Device ... The purpose of this review is to discuss recent trends in LVAD implantation strategies and to highlight significant improvements in clinical outcomes.

4. jacc.org jacc.org/doi/10.1016/j.jacc.2021.09.1362

Evolution of Late Right Heart Failure With Left Ventricular ... The purpose of this study was to determine the prevalence and severity of RHF over time and the association of RHF status at 3 months with 12-month outcomes ...

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.1040251/full

Prediction, prevention, and management of right ventricular ... Right ventricular failure (RVF) is a feared complication that occurs in 20–40% patients early after LVAD implantation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9671519/

Prediction, prevention, and management of right ventricular ... Right ventricular failure (RVF) is a feared complication that occurs in 20–40% patients early after LVAD implantation.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3961845/

Assessment of Right Ventricular Function in Left Ventricular ... In this article, we review the current evidence for preoperative assessment of RV function and RVF risk, with focus on cardiac imaging and specifically ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.027251

Left Ventricular Assist Devices: A Primer For the General ... Durable implantable left ventricular assist devices (LVADs) have been shown to improve survival and quality of life for patients with stage D heart failure.

9. jhltopen.org jhltopen.org/article/S2950-1334(25)00156-9/fulltext

Critical care management of right ventricular failure in ... More than 50% of children undergoing isolated left ventricular assist device (LVAD) implantation may develop right ventricular failure (RVF), an ...