NCT05866666

Brief Summary

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

May 10, 2023

Last Update Submit

November 20, 2023

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (7)

  • Cardiac Performance System electronic data for Cardiac Output

    Cardiac function metric measurement including Cardiac Output to report in L/m.

    10 minutes before cardiac catheterization procedure

  • Cardiac Performance System electronic data for Pulmonary Artery Pressure

    Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.

    10 minutes before cardiac catheterization procedure

  • Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure

    Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.

    10 minutes before cardiac catheterization procedure

  • Pulmonary Artery Catheter electronic data for Cardiac Output

    Cardiac function metric measurement including Cardiac Output to report in L/m.

    60 minutes during cardiac catheterization procedure

  • Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure

    Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.

    60 minutes during cardiac catheterization procedure

  • Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure

    Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.

    60 minutes during cardiac catheterization procedure

  • Echocardiography electronic data for Ejection Fraction

    Cardiac function measurement including left ventricle ejection fraction to report in percentage.

    15 minutes at a time prior to or after Pulmonary Artery Catheter procedure

Study Arms (1)

Cardiac Function Monitoring

Subjects scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure.

Device: Cardiac Performance System (NSR)

Interventions

Cardiac Performance System (NSR)DEVICE

Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function.

Cardiac Function Monitoring

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for cardiac catheterization procedure

You may qualify if:

  • Ability to provide written informed consent
  • years of age or older
  • Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

You may not qualify if:

  • Previous Heart Transplant
  • Presence of Left Ventricular Assist Device
  • Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
  • Surgical scars/wounds/bandages/ports at the site of sensor placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Yahaira Ortiz-Gonzalez, MD

    Orlando Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sensydia

CONTACT

6618774670info@sensydia.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

May 30, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)