Mitigating Post-Op RV Dysfunction After LVAD Implantation

Last updated: September 11, 2024
Sponsor: University of Chicago
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Standardized RV Management

Usual Care RV Management

Clinical Study ID

NCT05758194
IRB22-0972
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Undergoing durable LVAD implantation without plan for perioperative rightventricular mechanical circulatory support

Exclusion

Exclusion Criteria:

  • Patients with pre-operative right ventricular mechanical circulatory support orhaving high likelihood of requiring right ventricular mechanical circulatorysupport.

  • Patients with RV implantable cardiac device (ICD)/pacemaker lead who arepacemaker-dependent

  • Pregnant patients

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Standardized RV Management
Phase:
Study Start date:
March 22, 2023
Estimated Completion Date:
September 30, 2026

Study Description

The main purpose of this study is to learn more about protecting against RV dysfunction and RV failure (RVF) in patients receiving LVAD implantations.

This is a prospective, randomized controlled study that will include 20 patients with heart failure undergoing LVAD implantation. Patients will receive their LVAD implantation as part of routine care. Patients will be randomized 1:1 to one of two arms, 1) standardized RV management arm, and 2) usual care RV management arm, which are both consistent with standard of care (SOC).

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

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