Micra Transcatheter Pacing System Post-Approval Registry

NCT02536118 · tracked via the Priya Life Science Germany tracker

Sponsor

Medtronic

Phase

Observational

Started

2015-07

Last updated

2026-02-04

Condition(s) studied

Bradycardia

Investigational drug(s) / intervention(s)

Micra Transcatheter Pacing System

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.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Acute complication rate — 30-days
To estimate acute complication rate related to the Micra system and/or implant procedure.
Long-term complication free survival — 9 years
To estimate the chronic complication free survival rate of the Micra system.

Trial sites (156)

Facility	City	Region
—	Birmingham	Alabama
—	Los Angeles	California
—	Redwood City	California
—	New Haven	Connecticut
—	Washington D.C.	District of Columbia
—	Clearwater	Florida
—	Jacksonville	Florida
—	Safety Harbor	Florida
—	Atlanta	Georgia
—	Indianapolis	Indiana
—	West Des Moines	Iowa
—	Kansas City	Kansas
—	Edgewood	Kentucky
—	Louisville	Kentucky
—	Salisbury	Maryland
—	Silver Spring	Maryland
—	Takoma Park	Maryland
—	Boston	Massachusetts
—	Ann Arbor	Michigan
—	Lansing	Michigan
—	Ypsilanti	Michigan
—	Minneapolis	Minnesota
—	Rochester	Minnesota
—	Saint Cloud	Minnesota
—	Columbia	Missouri
—	Kansas City	Missouri
—	Morristown	New Jersey
—	Ridgewood	New Jersey
—	Huntington	New York
—	New York	New York
—	Poughkeepsie	New York
—	Durham	North Carolina
—	Raleigh	North Carolina
—	Akron	Ohio
—	Cincinnati	Ohio
—	Cleveland	Ohio
—	Columbus	Ohio
—	Toledo	Ohio
—	Oklahoma City	Oklahoma
—	Portland	Oregon

+ 116 more sites — see the full list on the official registry below.

More Medtronic trials in Germany

Enlighten Study: The EV-ICD Post Approval Registry Active, not recruiting

Product Surveillance Registry Recruiting

Lead Evaluation for Defibrillation and Reliability Post Approval Study Enrolling by invitation

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting

Other trials for the same condition

Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers Recruiting

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System Recruiting

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs) Recruiting

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting

Registry of Device Implantation Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02536118 on ClinicalTrials.gov ↗ ← All trials in Germany