Micra Transcatheter Pacing System Post-Approval Registry

Bradycardia Clinical Trial

Official title:

Micra Transcatheter Pacing System Post-Approval Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02536118
• Other study ID #: Micra Registry
• Status: Active, not recruiting
• Start date: July 2015
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry*. 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. *Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3100
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure

Exclusion Criteria:

• Patient who is, or is expected to be inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Micra Transcatheter Pacing System
The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Iceland,  Israel,  Italy,  Japan,  Kuwait,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Saudi Arabia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment	Micra System performance will be described following use in an MR environment. A listing of MRI related events, pacing impedance (ohms) and pacing threshold (volts) over time following MR exposure may be reported.	Up to 9 years
Primary	Acute complication rate	To estimate acute complication rate related to the Micra system and/or implant procedure.	30-days
Primary	Long-term complication free survival	To estimate the chronic complication free survival rate of the Micra system.	9 years
Secondary	Pacing impedance (ohms) and pacing threshold (volts)	Summary statistics of electrical performance 5-years post-implant measurements will be reported.	Up to 9 years
Secondary	Complications stratified by implant type	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.	Up to 9 years
Secondary	Estimate Micra System revision rate	Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.	Up to 9 years
Secondary	Estimate System Longevity	Summary statistics regarding battery length will be reported.	Up to 9 years
Secondary	Confirm the rate response operation of the Micra system	Analysis of treadmill testing data from patients implanted with Micra for at least 3 months. Rate response data collected in the registry will be combined with data from the FDA Investigational Device Exemption study (NCT 02004873).	Approximately 2 years