Clinical Trial: Micra Transcatheter Pacing System Post-Approval Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Micra Transcatheter Pacing System Post-Approval Registry

Brief Summary:

Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.

The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

Detailed Summary: The Micra Registry is a global, prospective, observational, multi-site registry. All patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post implant or until registry closure. Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years.
Sponsor: Medtronic

Current Primary Outcome:

• Acute complication rate [ Time Frame: 30-days ]
  The secondary objectives are descriptive in nature and are intended to gain additional information about the performance of the Micra System. There are no minimum sample size requirements for these objectives. To estimate acute complication rate related to the Micra system and/or implant procedure.
• Long-term complication free survival [ Time Frame: up to 9 years ]
  To estimate the chronic complication free survival rate of the Micra system.

Original Primary Outcome:

• Acute complication rate [ Time Frame: 30-days ]
  The secondary objectives are descriptive in nature and are intended to gain additional information about the performance of the Micra System. There are no minimum sample size requirements for these objectives. To estimate acute complication rate related to the Micra system and/or implant procedure.
• Long-term complication free survival [ Time Frame: 5 years ]
  To estimate the 5-year complication free survival rate of the Micra system.

Current Secondary Outcome:

• Pacing impedance (ohms) and pacing threshold (volts) [ Time Frame: Up to 9 years ]
  Summary statistics of electrical performance 5-years post-implant measurements will be reported.
• Complications stratified by implant type [ Time Frame: Up to 9 years ]
  A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness.
• Estimate Micra System revision rate [ Time Frame: Up to 9 years ]
  Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.
• Estimate System Longevity [ Time Frame: Up to 9 years ]
  Summary statistics regarding battery length will be reported.

Original Secondary Outcome:

• Pacing impedance (ohms) and pacing threshold (volts) [ Time Frame: Up to 5 years ]
  Summary statistics of electrical performance 5-years post-implant measurements will be reported.
• Complications stratified by implant type [ Time Frame: Up to 5 years ]
  A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness.
• Estimate Micra System revision rate [ Time Frame: Up to 5 years ]
  Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.
• Estimate System Longevity [ Time Frame: Up to 5 years ]
  Summary statistics regarding battery length will be reported.

Information By: Medtronic

Dates:
Date Received: August 17, 2015
Date Started: July 2015
Date Completion: August 2026
Last Updated: March 3, 2017
Last Verified: February 2017