Cardiac Performance System Data Collection Study

RECRUITING

I'm interested ...!!

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)

Conditions:

🦠 Cardiac Disease

🗓️ Study Start (Actual) 30 May 2023

🗓️ Primary Completion (Estimated) 31 May 2024

✅ Study Completion (Estimated) 31 May 2024

👥 Enrollment (Estimated) 115

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Orlando, Florida, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 22 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

First Submitted 10 May 2023
First Submitted that Met QC Criteria 10 May 2023
First Posted 19 May 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 20 November 2023
Last Update Posted 21 November 2023
Last Verified November 2023