NCT05528029

International Ledless Pacemaker Registry

International Ledless Pacemaker Registry (i-LEAPER)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Luigi Sacco University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study includes consecutive patients implanted with a pacemaker leadless device (Micra Transcatheter Pacing System; Medtronic, Inc., Minneapolis, MN, USA). Baselines characteristics, procedural and clinical outcomes will be collected and analyzed.

Conditions

• Block Complete Heart
• Atrial Fibrillation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-09-06
• Last updated: 2022-12-23

Locations

12 sites across 3 countries: Belgium, Italy, Switzerland

Regulatory

• FDA-regulated device study