Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHemoCept Inc.
About this trial
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
Subjects can be any gender but must be between (and including) the ages of 18 and 80.
Subject ls being treated by the participating healthcare facility .
Subject is able and willing to provide informed consent and HIPM authorization.
Disqualifiers
Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
Long O-T syndrome
Cardiac channelopathies
Seizures
Trial population
Subjects will be between 18 and 80 and above who meet all the Inclusion/Exclusion criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Correlation of HemoCept device measurements with aortic valve pressure gradient changes.
The primary endpoint is the ability of the HemoCept device to properly detect changes consistent with aortic valve pressure gradient values, measured by echocardiogram pre and post TAVR procedure.
Time frame
Perioperative; immediately before procedure, and up to 24 hours after the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov