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Clinical Trials in the USA / NCT07205341
Recruiting Observational

Detecting Changes in Arterial Blood Volume and Cardiac Efficiency

NCT07205341 · tracked via the Priya Life Science USA tracker
Sponsor
HemoCept Inc
Phase
Observational
Started
2025-04-29
Last updated
2026-04-13

Condition(s) studied

Aortic Valve Stenosis

Study summary

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Correlation of HemoCept device measurements with aortic valve pressure gradient changes. — Perioperative; immediately before procedure, and up to 24 hours after the procedure
    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.

Trial sites (1)

FacilityCityRegionStatus
Boulder Heart Boulder Colorado Recruiting

More HemoCept Inc. trials in the USA

Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization Recruiting

Other trials for the same condition

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR Recruiting
Early Feasibility Study for the Foldax Tria Aortic Heart Valve Active, not recruiting
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material Recruiting
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial Active, not recruiting
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07205341 on ClinicalTrials.gov ↗ ← All trials in the USA