Non-invasive Pulmonary Artery Prediction (ADOPTS) (ADOPTS)

December 9, 2022 updated by: Silverleaf Medical Sciences INC

Feasibility Study to Determine if Novel Wearable Monitoring System and Machine-Learning Algorithm Can Model Continuous Pulmonary Artery Pressure Recordings in Human Subjects

A proprietary machine-learning algorithm has been developed to model continuous pulmonary artery pressure (PAP), a physiologic marker of cardiopulmonary function. The algorithm was developed from PAP recordings obtained during invasive right heart catheterization. The study will evaluate whether this algorithm can perform as well when embedded into a non-invasive wearable device that records EKG, heart sounds, and thoracic impedance has yet to be established.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A prototype device will be supplied by Silverleaf Medical Science (Redlands, CA) to record these signals. This study will take place at Loma Linda VA, in the cardiac catheterization lab as an add-on to clinically-indicated right heart catheterizations, and under the supervision of heart failure and interventional cardiologists. The investigators will screen and enroll 20 Veterans who consent to participate in the study. Veterans who decline to consent and vulnerable populations will be excluded from the study. The investigators will obtain simultaneous recordings from the prototype device (EKG, heart sounds, and thoracic impedance) and from the PAP catheter , both at rest (5 minutes), and in response to physiological maneuvers: hand grip, passive leg raise, and Valsalva (1 minute recordings with 1-minute breaks). De-identified recordings from the prototype device will be shared with the team at Silverleaf Medical Science to derive a computed PAP. The investigators will test the hypothesis that computed PAP is no different than measured PAP. If the algorithm can produce a computed PAP with high accuracy,'[it would be the first wearable system to non-invasively report PAP.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92357
        • Loma Linda Veterans Administration Healthcare System
        • Contact:
          • Jay Patel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study investigators will screen up to 50 Veterans undergoing right heart catheterization for clinical indications with the intention to consent up to 20 Veterans. Veterans will be screened by study investigators. Veterans who decline to consent and vulnerable populations (pregnant, incapacitated, incarcerated) will be excluded from the study.

Description

Inclusion Criteria:

  • Written informed consent and authorization to use and disclose health information.
  • 20 years of age or older.
  • Diagnosis of HF for >3 months, with preserved or reduced left ventricular ejection fraction (LVEF).
  • Female subjects of childbearing age with a negative urine or serum pregnancy test at the time of the right heart cauterization procedure and trial.

Exclusion Criteria:

  • Active infection.
  • Unable to tolerate a right heart catheterization (RHC), in the investigator's opinion.
  • Implantation of cardiac resynchronization therapy (CRT)<3 months before enrollment.
  • Enrolled in concurrent studies that may confound the results of this study.
  • Clinical condition that would not allow them to complete the study, in the investigator's opinion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
right heart catheterization cohort
The study investigators will screen up to 50 Veterans undergoing right heart catheterization for clinical indications with the intention to consent up to 20 Veterans. Veterans will be screened by study investigators. Veterans who decline to consent and vulnerable populations (pregnant, incapacitated, incarcerated) will be excluded from the study.
Diagnostic test: right heart catheterization
Connect to a heart monitor to record heart rate, blood pressure and blood oxygen levels Place sterile sheets on chest and neck (or groin area) Clean the skin over the neck or groin Give local anaesthetic to numb the area (this may sting a little when it is given) Gently pass a catheter into a vein to the heart Record pressure readings from the heart chambers and lungs Give medication, depending on heart's pressure readings Remove the catheter and apply pressure where it was inserted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Outcome
Time Frame: the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes
The primary outcome of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous PAP measurement obtained during right heart catheterization.
the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silverleaf Medical Sciences INC

Collaborators

VA Loma Linda Health Care System

Investigators

  • Principal Investigator: Jay Patel, Loma Linda Veterans Administration Healthcare System
  • Study Director: Islam Abudayyeh, Silverleaf Medical Sciences INC
  • Study Chair: Jianwei Zheng, Ph.D., Silverleaf Medical Sciences INC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADOPTS_VALL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on right heart catheterization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe