Recruiting

Pulmonary Artery Prediction

Sponsor:

Silverleaf Medical Sciences INC

Code:

NCT05622695

Conditions

Heart Failure

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

catheterization

Study Details

Brief summary:

Cardiac remote monitoring devices have expanded our ability to track physiological changes used in the diagnosis and management of patients with cardiac disease. Implantable remote monitoring technologies have been shown to predict heart failure events, and guide therapy to reduce heart failure hospitalizations. The CardioMEMs System, the most studied and established remote monitoring system, relies on a pulmonary artery implant for continuous PAP measurement. However, there are no commercially available wearable systems that can reproduce continuous PAP tracings.

This study aims to determine if a machine-learning algorithm with data from a wearable cardiac remote-monitoring system incorporating EKG, heart sounds, and thoracic impedance can reproduce a continuous PAP tracing obtained during right heart catheterization.

Conditions

Heart Failure

Pulmonary Arterial Hypertension

Study ID

NCT05622695

Start date

Oct 30, 2022

Status verified date

Nov, 2022

Completion date

Aug 31, 2023

Anticipated

Primary completion date

Apr 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subjects age 18+ years
2. Undergoing a right heart cardiac catheterization or in the cardiac care unit with active monitoring using an arterial line or Swan-Ganz catheter.

Exclusion Criteria:

1. Vulnerable population
2. Unable to consent for any reason
3. Unstable patient
4. Known skin reaction to latex or adhesives

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Catheterization Arm

Participants will be limited to adults older than 18 years of age, able to consent, planned for the cardiac catheterization lab for a right heart catheterization or in the cardiac care unit with an existing arterial line or Swan-Ganz catheter actively measuring the pulmonary artery pressure on a continuous basis.

Interventions

catheterization

Swan-Ganz catheterization (also called right heart catheterization or pulmonary artery catheterization) is the passing of a thin tube (catheter) into the right side of the heart and the arteries leading to the lungs. It is done to monitor the heart's function and blood flow and pressures in and around the heart.

Primary outcome measure

  • The correlation of pulmonary artery pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm [ Time Frame: the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes. ]
  • The correlation of pulmonary artery wedge pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm [ Time Frame: the Swan-Ganz catheter obtains wedge pressures first for a minimum of 20 seconds (20-30 seconds). ]

Central Contacts and Locations

Central contacts

Jianwei Zheng, Ph.D.

9493298388zheng@slmedsci.com

Locations

PIH Good Samaritan Hospital

Recruiting

Los Angeles, California, United States, 90017

Contacts

Ihab Alomari, Dr.

505-573-1457

More Information

Sponsor

Silverleaf Medical Sciences INC

Last update posted

Nov 21, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Silverleaf Medical Sciences INC on 2022-11-21.