Cardiac Performance System Data Collection Study

Sensydia

Status: Enrolling

Conditions: Cardiac Disease

Treatments: Device: Cardiac Performance System (NSR)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05866666

CPS_ORLANDO

Details and patient eligibility

About

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)

Full description

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)

Enrollment: 115 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability to provide written informed consent
• 22 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.

Exclusion criteria

• 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

Trial design

115 participants in 1 patient group

Cardiac Function Monitoring

Description:

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

Treatment:

Device: Cardiac Performance System (NSR)