Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT device

Completed

• Conditions: exercise tolerance; minute ventilation; 10082206

• Registration Number: NL-OMON35038
• Lead Sponsor: Sorin Group Nederland N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Indication for biventricular defibrillator and chronic heart failure.

Exclusion Criteria

Contraindication for standard pacing.
Contraindication for ICD therapy.
Abdominal implantation site.
Acute myocarditis.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity of the PhD-inication in detecting HF events (device indicated) in<br /><br>relation to all HF-related clinical events.<br /><br>At least one of the following present: hospital admission, emergency room visit<br /><br>requiring intravenous drug treatment, invasive intervention, admission to<br /><br>intensive care, initiation of intravenous drug treatment without hospital<br /><br>admission, death.<br /><br><br /><br>Mean number of false positives per year per patient.<br /><br>Success is defined as mean rate for study population statistically<br /><br>significantly less than two false positives per patient per year.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Sensitivity of Paradym PhD-indication in detecting HF events (device indicated<br /><br>HF event) in relation to all HF events related to oral treatment modification.<br /><br><br /><br>Reported co-morbidity that was related to a PhD-indication in the device memory.<br /><br><br /><br>Reported Adverse Events.</p><br>