Novel On-body Evaluation of Cardiac Health for Oncology (NOECHO)

Skribe Medical

Status: Invitation-only

Conditions: Cardiotoxicity; Heart Failure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07158450

SKR-LVEF-001

Details and patient eligibility

About

The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Undergoing an echocardiogram irrespective of participation in this study
• Willing and able to provide informed consent prior to any study-related activity

Exclusion criteria

• Have a documented allergy to potential tissue contacting system materials

• Have been diagnosed with one or more of the following cardiac diseases/conditions that distort cardiac activity:

  1. Severe valve disease
  2. Severe right ventricular dilation or dysfunction
  3. Significant arrhythmias or conduction abnormalities
  4. Active ischemia or myocardial infarction within the last 3 months

• Have an active implantable cardiac device

• Have any condition that would cause inaccurate TTE measurements

Trial design

50 participants in 3 patient groups

Healthy

Description:

No known or suspected cardiac disease

Borderline LVEF

Description:

Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction

Reduced LVEF

Description:

Known diagnosis of reduced left ventricular ejection fraction