Mitigating Post-Op RV Dysfunction After LVAD Implantation

NCT ID: NCT05758194

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2025-03-28

Brief Summary

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

Detailed Description

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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).

Conditions

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Heart Failure Right Ventricular Dysfunction Right Ventricular Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standardized RV Management

Physicians will follow prespecified parameters for RV management (consistent with SOC)

Group Type ACTIVE_COMPARATOR

Standardized RV Management

Intervention Type OTHER

Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)

Usual Care RV Management

Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)

Group Type ACTIVE_COMPARATOR

Usual Care RV Management

Intervention Type OTHER

No standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)

Interventions

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Standardized RV Management

Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)

Intervention Type OTHER

Usual Care RV Management

No standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support

Exclusion Criteria

* Patients with pre-operative right ventricular mechanical circulatory support or having high likelihood of requiring right ventricular mechanical circulatory support.
* Patients with RV implantable cardiac device (ICD)/pacemaker lead who are pacemaker-dependent
* Pregnant patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Grinstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB22-0972

Identifier Type: -

Identifier Source: org_study_id

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