Concept and Feasibility Investigation of Planning to Live and Easy Echo for Mitral Interventions

Completed

Conditions: structural heart disease
valve disease
10046973

Registration Number: NL-OMON44552

Lead Sponsor: Philips

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Subjects undergoing an SHD procedure and/or
- Subjects undergoing SHD procedural planning
- Subject is 18 years of age or older
- Subject is able to give informed consent, or of legal age to give informed consent per national law

Exclusion Criteria

- Subject unable or unwilling to sign informed consent
- Subject participates in a potentially confounding drug or device trial during the course of the study.
- Subject meets an exclusion criteria according to national law (e.g. Age, pregnant woman, breast feeding woman)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is clinical feedback on workflow, usability, and clinical<br /><br>impact of the device:<br /><br>1) Define critical anatomical structures, markers, anatomical views, and<br /><br>measurements on CT and ultrasound required for mitral and other structural<br /><br>heart disease procedures<br /><br>2) Define critical overlay annotations for clinically significant guidance<br /><br>3) Generate hypotheses on measurable impact parameters of imaging</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include:<br /><br>- Procedure time, radiation dose (DAP and AK), contrast agent used during<br /><br>interventions<br /><br>- Procedural parameters such as number of positioning attempts, complication<br /><br>rates, adverse events, adverse device effects, device deficiencies that could<br /><br>led to an SAE.</p><br>