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NCT05678530RecruitingAccepts Healthy Volunteers

Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

Prolaio

Start Date

6/6/2019

Completion Date

12/31/2027

Summary

In this study, the hypothesis being explored is that peak VO2 and potentially other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected during activities of daily living using FDA-cleared wearable biosensors worn by study participants. This study will aim to collect data using wearable biosensors from standard of care patients toward the development of an algorithm that can estimate peak VO2 (eVO2peak) from biosensor data. In addition, this study will explore to further develop other estimated measurements typically reported in CPET, such as VE/VCO2 slope, as well as selected and measures of Left Ventricular Function (diastolic and systolic) typically reported in echocardiogram; instead using wearable biosensors from standard of care testing. A total of 2000 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 1900 participants.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Willing and able to comply with protocol procedures and available for the duration of the study. 2. Willing to sign and date informed consent document for study participation. 3. Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care Exclusion Criteria: 1. Participant is pregnant, lactating or ≤30 days post-partum. 2. Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing). • If participant has an indwelling cardiac device and programming cannot be sufficiently ascertained to assure sinus node competence and lack of atrial pacing, the patient should be excluded. 3. Barostim (™) or similar noncardiac electrical pulse generating device in situ. 4. Complex congenital heart disease (even repaired or palliated) with the following exception: • Biventricular physiology without severe valvar dysfunction (e.g. free pulmonary insufficiency) at the discretion of the investigator. 5. Any history of allergy to adhesive 6. Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach a respiratory exchange ratio of 1.0, or perform a maximal CPET in the judgement of the investigator, and/or any limitations pertaining to obtaining a complete Echo

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Conditions

Cardiopulmonary

Locations

Mayo Clinic Arizona

Scottsdale, Arizona 85259

United States

VA Palo Alto Healthcare System

Palo Alto, California 94304

United States

University of California San Francisco

San Francisco, California 94143

United States

The Lundquist Institute

Torrance, California 90502

United States

Nemours Cardiac Center

Wilmington, Delaware 19803

United States

Memorial Healthcare System, Office of Human Research

Hollywood, Florida 33021

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

New Generation of Medical Research

Naples, Florida 34116

United States

physIQ

Chicago, Illinois 60606

United States

University of Illinois Hospital & Health Sciences System

Chicago, Illinois 60608

United States

Advocate Aurora Health Institute

Oakbrook Terrace, Illinois 60181

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Baylor Scott & White Research Institute

Dallas, Texas 75246

United States

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas 75093

United States

Intermountain Medical Center

Murray, Utah 84107

United States

Eastern Health Cardiac Rehabilitation

St. John's, Newfoundland and Labrador A1N3J5

Canada