20 Participants Needed

RV Management After LVAD Implantation for Heart Failure

AJ
Overseen ByAnthony J Kanelidis, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.

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 data supports the effectiveness of the treatment Standardized RV Management for managing right ventricular failure after LVAD implantation?

The research highlights that right ventricular failure (RVF) is a common complication after left ventricular assist device (LVAD) implantation, and effective management strategies are crucial. Standardized RV Management may include supportive therapies like pulmonary vasodilators and inotropes, which are known to help manage RVF by improving heart function and blood flow.12345

Is RV management after LVAD implantation safe for humans?

Managing right ventricular (RV) failure after left ventricular assist device (LVAD) implantation is generally safe when done with careful monitoring and appropriate interventions. Studies show that using minimally invasive techniques and new devices can reduce complications, although RV failure remains a risk that needs to be managed effectively.23678

How does the treatment for RV management after LVAD implantation differ from other treatments?

The treatment for RV management after LVAD implantation is unique because it involves a standardized approach to managing right ventricular failure, which includes optimizing RV function, using supportive therapies like pulmonary vasodilators and inotropes, and potentially employing surgical interventions such as RV assist devices. This approach is tailored to address the specific challenges of RV failure that occur after LVAD implantation, which are not fully addressed by existing treatments.127910

Research Team

JG

Jonathan Grinstein, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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.
I am 18 years old or older.

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

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

Treatment Details

Interventions

  • Standardized RV Management
  • Usual Care RV Management
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Group I: Usual Care RV ManagementActive Control1 Intervention
Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)
Group II: Standardized RV ManagementActive Control1 Intervention
Physicians will follow prespecified parameters for RV management (consistent with SOC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

References

Right ventricular failure after left ventricular assist devices. [2022]
Preoperative evaluation and perioperative management of right ventricular failure after left ventricular assist device implantation. [2013]
Minimally invasive surgery for left ventricular assist device implantation is safe and associated with a decreased risk of right ventricular failure. [2022]
Prediction, prevention, and management of right ventricular failure after left ventricular assist device implantation: A comprehensive review. [2022]
[Rise of the machines? Left ventricular assist devices for treatment of severe heart failure]. [2018]
Left ventricular vs. biventricular mechanical support: Decision making and strategies for avoidance of right heart failure after left ventricular assist device implantation. [2022]
Right ventricular failure after LVAD implantation: prevention and treatment. [2022]
Novel percutaneous dual-lumen cannula-based right ventricular assist device provides effective support for refractory right ventricular failure after left ventricular assist device implantation. [2020]
Right ventricular failure after left ventricular assist device implantation: a review of the literature. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Prevention and Treatment of Right Ventricular Failure During Left Ventricular Assist Device Therapy. [2018]