Cardiac Performance System Data Collection Study

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)

Conditions

Cardiac Disease

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Study Overview

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Study Details

Study overview

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)

Cardiac Performance System Data Collection Study

Cardiac Performance System Data Collection Study

Condition
Cardiac Disease
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Health, Orlando, Florida, United States, 32806

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Sensydia Corporation,

Yahaira Ortiz-Gonzalez, MD, PRINCIPAL_INVESTIGATOR, Orlando Health

Study Record Dates

2024-05-31