Pre-Market Algorithm Validation Study

N/ACompletedNCT02200601

Heart Force Medical Inc.30 enrolled

Overview

The study sponsor has developed a patented medical device called Seipher Wellness. This is a non-invasive medical device that assesses heart health based on established cardiac parameters; timing events of the cardiac cycle. These are specific parameters captured and analyzed by the device. A ratio of two specific timing parameters provides an assessment of the subject's overall heart health. The aim of this study is to validate the device algorithm across a range of subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Seipher WellnessDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older * able to understand the informed consent document * willing to participate * ambulatory volunteers Exclusion Criteria: * individuals with visible scar(s) or deformity in the test area of the chest * non-ambulatory subjects * enrolled in another concurrent study or trial * exercised excessively within the last 4 hours * unwilling to sign informed consent * female subjects who are pregnant, suspected or planning to become pregnant or breast-feeding

Locations (1)

Integrative Naturopathic Medical Centre

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Systolic Time Intervals (STI) value

Time frame: Day 1

Data from ClinicalTrials.gov

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