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International Ledless Pacemaker Registry (i-LEAPER)

L

Luigi Sacco University Hospital

Status

Enrolling

Conditions

Atrial Fibrillation
Block Complete Heart

Treatments

Device: Leadless Pacemaker (Micra)

Study type

Observational

Funder types

Other

Identifiers

NCT05528029
Hsacco2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: All patients implanted with the MIcra leadless pacing system

  • At least 1 month of follow up
  • At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center

Exclusion Criteria:

  • None

Trial contacts and locations

12

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Central trial contact

Giovanni B Forleo, MD, PhD; Marco Schiavone, MD

Data sourced from clinicaltrials.gov

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