Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™

N/AWithdrawnNCT03751904

Signature Medical, Inc.

Overview

AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Heart Failure，Congestive

Interventions

AcoustiCareDEVICE

Electronic stethoscope

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female subjects between the ages of 18 - 80 years 2. Willing and able to sign informed consent form 3. Normal subjects without a history of heart disease who are recruited from the surrounding community 4. Subjects with heart failure undergoing treatment in a hospital setting Exclusion Criteria: 1. Hemodynamic instability (Systolic BP\>180 or \<90 and Diastolic BP\>90 and \<60) 2. Acute coronary syndrome 3. Prior heart transplant recipients 4. Subjects who are pacemaker dependent 5. Severe obesity (body mass index \> 40 kg/m2) 6. Subjects who are pregnant

Outcomes

Primary Outcomes

Incidence of Adverse Events

The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study

Time frame: Subjects will be assessed for adverse events through study completion, an average of 1 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.