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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
1,002 Previous Clinical Trials
817,830 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team currently recruiting participants for this investigation?

"According to gleanings on clinicaltrials.gov, this research endeavour is no longer recruiting participants as the last update was February 24th 2023 and it was originally posted April 1st 2023. Despite that, there are currently 719 other trials actively seeking patients."

Answered by AI

What is the primary focus of this medical research?

"The primary measure of this research will be the alteration in cardiac power output (CPO) from prior to LVAD insertion up to post-surgical day 3. Secondary outcomes encompass RV failure according to 2020 ARC guidelines, total number of inotropes used, and the amount of vasopressors utilized."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mitigating Post-Op RV Dysfunction After LVAD Implantation
2023. "Mitigating Post-Op RV Dysfunction After LVAD Implantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05758194.
~10 spots leftby Apr 2025
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