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RV Management After LVAD Implantation for Heart Failure
N/A
Waitlist Available
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
No Placebo-Only Group
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.
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.
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through duration of hospitalization, up to 30 days following lvad implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through duration of hospitalization, up to 30 days following lvad implantation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Hospital length of stay
ICU length of stay
Inotropic therapy
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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)
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,053 Previous Clinical Trials
759,054 Total Patients Enrolled
12 Trials studying Heart Failure
1,482 Patients Enrolled for Heart Failure
Jonathan Grinstein, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
1 Total Patients Enrolled
1 Trials studying Heart Failure
1 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility 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.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.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care RV Management
- Group 2: Standardized RV Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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