Menu
Recruiting NCT07205341

Detecting Changes in Arterial Blood Volume and Cardiac Efficiency

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Clinical Study to Assess Correlation Between Arterial Blood Volume Status and Cardiac Efficiency, and HemoCept Device Data in Trans-Aortic Valve Replacement (TAVR} Surgery

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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Boulder Heart — Boulder

Identifiers

NCT: NCT07205341 · PRT-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗