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RV Management After LVAD Implantation for Heart Failure

N/A
Recruiting
Led By Jonathan Grinstein, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through duration of hospitalization, up to 30 days following lvad implantation
Awards & highlights

Study Summary

This trial tests ways to protect the heart's right side when a device to help the left side is implanted.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial compares different management strategies rather than medications, specific side effects aren't listed like drug trials. However, general risks may include complications from surgery and potential impact on RV function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am getting a long-term left ventricular assist device without support for the right side of my heart.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through duration of hospitalization, up to 30 days following lvad implantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and through duration of hospitalization, up to 30 days following lvad implantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7
+12 more
Secondary outcome measures
Hospital length of stay
ICU length of stay
Inotropic therapy
+10 more

Trial Design

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 Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,012 Previous Clinical Trials
734,050 Total Patients Enrolled
Jonathan Grinstein, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Standardized RV Management (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05758194 — N/A
Right Ventricular Dysfunction Research Study Groups: Usual Care RV Management, Standardized RV Management
Right Ventricular Dysfunction Clinical Trial 2023: Standardized RV Management Highlights & Side Effects. Trial Name: NCT05758194 — N/A
Standardized RV Management (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05758194 — N/A
~9 spots leftby Jun 2025
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