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NCT06039176 · ClinicalTrials.gov registry record

Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future

A clinical trial of Hypertension and Stroke, sponsored by International Consortium of Circulatory Assist Clinicians.

Recruiting
Registry status
150
Enrollment target
7
Study locations

NCT06039176 is a study of Hypertension and Stroke that is actively recruiting participants, run by International Consortium of Circulatory Assist Clinicians. The registered enrollment target is 150 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT06039176, a study of Hypertension and Stroke, is actively recruiting participants, sponsored by International Consortium of Circulatory Assist Clinicians.

RECRUITING
Registry status
150 participants
Enrollment target
7
Study locations

Study Summary

Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation. Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time fo

Interventions

  • DEVICE HeartMate 3 (R) left ventricular assist device

Study Locations (7)

California

  • UCSF - San Francisco

Florida

  • University of Florida - Gainesville

Illinois

  • University of Chicago - Chicago

Kansas

  • University of Kansas Medical Center - Kansas City

Minnesota

  • Mayo Clinic-Rochester - Rochester

South Carolina

  • MUSC - Charleston

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2023-10-27
Est. Completion 2026-12-30

What the Registry Record Tells You About NCT06039176

The ClinicalTrials.gov registry entry for NCT06039176 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (96% lower). The listed sponsor is International Consortium of Circulatory Assist Clinicians, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which HeartMate 3 (R) left ventricular assist device is the first listed.

NCT06039176 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT06039176 about?

NCT06039176 is a clinical study titled "Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future". Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from ...

What is the current status of trial NCT06039176?

This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2023-10-27. Estimated completion is 2026-12-30.

What conditions does trial NCT06039176 study?

This clinical trial studies the following conditions: Hypertension, Stroke, Frailty, Infections, Right Heart Failure.

What interventions are being tested in trial NCT06039176?

The interventions under investigation include: HeartMate 3 (R) left ventricular assist device (DEVICE).

Who is sponsoring clinical trial NCT06039176?

This trial is sponsored by International Consortium of Circulatory Assist Clinicians, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06039176 being conducted?

This trial has 7 study locations across California, Florida, Illinois, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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