Model 20066 LV Lead Study

Withdrawn

• Conditions: 10019280; Heart failure

• Registration Number: NL-OMON37840
• Lead Sponsor: Medtronic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Patient meets CRT inclusion criteria according to the guidelines

Exclusion Criteria

• Patient has a previous complete atrial based biventricular CRT system
• Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing AEs from previous unsuccessful attempt
• Patient has known coronary venous vasculature that is inadequate for lead placement

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the implant procedure related and lead related complications of the<br /><br>Model 20066 LV lead during the first month of follow up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the implant success rate of the Model 20066 lead.</p><br>