International Ledless Pacemaker Registry

Summary

The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers.

The aim of this multi-center study is to assess the clinical outcomes of patients implanted with Micra LLPM in real life, in different clinical scenarios.

Conditions

• Block Complete Heart
• Atrial Fibrillation

Interventions

DEVICE

Leadless Pacemaker (Micra)

Micra leadless pacemaker is implanted in the right ventricle via femoral vein. The Micra introducer/dilator assembled system is inserted over a stiff guidewire in the right atrium. After the removal of the guidewire and the dilator, the delivery system is advanced into the introducer and the Micra is placed under fluoroscopy guidance, preferably in the septal region of the right ventricle.

Sponsors & Collaborators

• Università degli Studi di Brescia

  collaborator OTHER

• Centro Cardiologico Monzino

  collaborator OTHER

• University Hospital, Zürich

  collaborator OTHER

• Azienda Ospedaliera Cardinale G. Panico

  collaborator OTHER

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• Ospedale V. Fazzi

  collaborator OTHER

• Ospedali Riuniti Ancona

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Università degli Studi di Ferrara

  collaborator OTHER

• University of Padova

  collaborator OTHER

• Luigi Sacco University Hospital

  lead OTHER

Principal Investigators

• Giovanni B Forleo, MD, PhD · Luigi Sacco University Hospital

• Gianfranco MItacchione, MD, PhD · Luigi Sacco University Hospital

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2024-12-31

Completion

2024-12-31

FDA Device

Yes

Countries

• Belgium
• Italy
• Switzerland

Study Locations