Pivotal Study for the Cardiac Performance System (CPS)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Sensydia Corporation
Study ID
NCT06870591
Status
Recruiting

Conditions

  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cardiac Performance System (CPS) — DEVICE
    CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.

Study Details

This multi-center, observational study evaluates the accuracy of the Cardiac Performance System (CPS), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart catheterization. The study compares CPS measurements to invasive measurements to assess agreement and potential clinical utility.

Key Dates

Start date
Apr 22, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: CPS Measurement Group
    Participants undergoing clinically indicated right heart catheterization will receive a single, non-invasive measurement using the Cardiac Performance System (CPS) before their scheduled procedure. The study aims to compare CPS results with standard invasive hemodynamic measurements.

Primary Outcome Measure

Cardiac Performance System electronic data for Pulmonary Pressure [ Time Frame: Single measurement prior to right heart catheterization ]

Locations (10)

FacilityCityStateZIPSite coordinators
Huntsville Hospital Heart CenterHuntsvilleAlabama35801
Principal Investigator
256-519-8472
Endeavor HealthEvanstonIllinois60201
Principal Investigator
847-570-2250
Hackensack University Medical CenterHackensackNew Jersey07601
Principal Investigator
551-996-2255
Jersey Shore University Medical CenterNeptune CityNew Jersey07753
Principal Investigator
551-996-2255
Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew YorkNew York10032
Principal Investigator
212-305-5064
The Ohio State University Medical CenterColumbusOhio43210
Principal Investigator
614-685-4619
University of Pennsylvania - Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104
Principal Investigator
215-662-4484
Medical University of South CarolinaCharlestonSouth Carolina29425
Principal Investigator
843-792-2300
The Stern Cardiovascular Foundation, Inc. / Baptist Memorial HospitalGermantownTennessee38138
Principal Investigator
901-271-1000
Baylor College of MedicineHoustonTexas77030
Principal Investigator
713-798-1297

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