NCT02951104

Brief Summary

Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

October 27, 2016

Last Update Submit

March 8, 2022

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Cardiac output measurement correlation at baseline

    Correlation between cardiac output measurement between USCOM system and Fick and thermodilution methods of cardiac output measurement (standard of care)

    30 minutes

Secondary Outcomes (1)

  • Cardiac output measurement correlation after vasodilator testing

    30 minutes

Study Arms (1)

USCOM

EXPERIMENTAL
Device: Ultrasonic Cardiac Output Monitor (USCOM) system

Interventions

Ultrasonic Cardiac Output Monitor (USCOM) systemDEVICE
USCOM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Diagnosis of Group 1 or Group 4 PAH based on PAPm \> 25 mmHg, PAWP \<15 mmHg, PVR \>3 WU and consistent clinical history. Note: for logistical reasons, patients at high suspicion for Group 1 or Group 4 PAH will sign informed consent to have the USCOM system applied during right heart catheterization before the procedure; if it is found that the patient does not meet the definition of Group 1 or Group 4 PAH during right heart catheterization, he/she will be excluded.
  • Willingness and ability to comply with study procedures.
  • No known hypersensitivity to the components of USCOM electrodes

You may not qualify if:

  • Unwillingness to sign informed consent or inability or unwillingness to comply with study procedures
  • Evidence of postcapillary pulmonary hypertension on right heart catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 1, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

US(1)