Detecting Changes in Arterial Blood Volume and Cardiac Efficiency

N/ARecruitingNCT07205341

HemoCept Inc.20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Stenosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 requires a trans-aortic valve replacement. * Subject is able and willing to provide informed consent and HIPM authorization. * Subject is able and willing to meet all study requirements. Exclusion Criteria: * Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study. * Subject has a personal medical history that includes: * Long O-T syndrome * Cardiac channelopathies * Seizures

Locations (1)

Boulder Heart

Boulder, Colorado, United States

RECRUITING

Outcomes

Primary Outcomes

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 procedure

Central Contacts

Katharine Adkins

CONTACT

303-442-2395 kathari.adkins@bch.org

Data from ClinicalTrials.gov

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