A Prospective, Nonrandomized, Noninvasive Study to Compare Nexfin CO-trek Cardiac Output with Trans-Thoracic Echo Cardiography Cardiac Output

Completed

• Conditions: specifieke aandoeningen zijn niet van belang voor het onderzoek; daar het onderzoek in een cardiologische omgeving uitgevoerd zal worden, zullen meeste proefpersonen cardiologische aandoeningen hebben; N.A.

• Registration Number: NL-OMON38784
• Lead Sponsor: Edwards Lifesciences LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Potential Subjects must:
- be at least 18 years of age
- must give signed written informed consent

Exclusion Criteria

Subjects will be excluded if any of these items exist:
1. Aortic valve regurgitation
2. Aortic stenosis or aneurysms
3. History of uncontrolled cardiac arrhythmia
4. Any peripheral vascular disease or conditions such as Raynaud*s disease or Buerger*s disease
5. Insufficient perfusion of the digits
6. Inability to place the finger cuff appropriately due to subject anatomy or condition
7. Known pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cardiac output obtained with the ccNexfin system and with TTE and their<br /><br>comparability as determined by Bland-Altman analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in cardiac output obtained with the ccNexfin system and with TTE and<br /><br>their comparability as determined by correlation / concordance analysis.<br /><br>Incidence of adverse events will be registered. </p><br>