MICRA Transcatheter Pacing Study

Completed

• Conditions: bradycardia; slow heart rate; 10007521

• Registration Number: NL-OMON38829
• Lead Sponsor: Medtronic Trading NL BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Subjects who have a Class I or II indication for implantation of a single chamber pacemaker according to ACC/AHA/HRS 2008 guidelines and any national guidelines.

Exclusion Criteria

Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm).
**NOTE: After the 1st 25 usable 1-month holters, the steering committee will conduct a safety review and assess whether this criterion can be removed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>See protocol page 22-24, 84-95<br /><br><br /><br>Primary Objectives:<br /><br>• Demonstrate that the freedom from acute major complications related to the<br /><br>Micra system and/or procedure at 6 months post-implant is greater than 83%<br /><br>• Demonstrate that the percentage of subjects with an adequate pacing capture<br /><br>threshold at 6-months post-implant exceeds 80%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>See protocol page 24, 95-100<br /><br><br /><br>Secondary Objectives:<br /><br>• Demonstrate the accuracy of Micra ventricular capture management pacing<br /><br>thresholds compared to manual pacing capture thresholds.<br /><br>• Demonstrate the rate response operation of the Micra system.</p><br>