Clinical trial NCT05528029: International Ledless Pacemaker Registry
Official title: International Ledless Pacemaker Registry (i-LEAPER)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Block Complete Heart
Atrial Fibrillation
Keywords: leadless pacing
Lead sponsor: Luigi Sacco University Hospital
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Brescia
name: Centro Cardiologico Monzino
name: University Hospital, Zürich
name: Azienda Ospedaliera Cardinale G. Panico
name: Azienda Ospedaliera San Gerardo di Monza
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: San Raffaele University Hospital, Italy
name: Ospedale V. Fazzi
name: Ospedali Riuniti Ancona
name: Universitair Ziekenhuis Brussel
name: Università degli Studi di Ferrara
name: University of Padova
First posted: 2022-09-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in whom a MIcra was implanted for a cardiac bradyarrhythmia.

Brief 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.

Eligibility 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

Primary outcomes:
measure: All cause mortality
timeFrame: through study completion, an average of 2 years
measure: Implant complication rates
timeFrame: during and immediately after the intervention
measure: Electrical performance of the pacing system
timeFrame: Through study completion, an average of 2 years
measure: Electrical performance of the pacing system
timeFrame: Through study completion, an average of 2 years
measure: Electrical performance of the pacing system
timeFrame: Through study completion, an average of 2 years
measure: Upgrading with a different pacing system
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit
city: Ancona
country: Italy
facility: Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT)
city: Bologna
country: Italy
facility: Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Lecce
country: Italy
facility: Cardiology Unit, Vito Fazzi Hospital, Lecce (IT)
city: Milano
country: Italy
facility: Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS
city: Milano
country: Italy
facility: Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
city: MIlano
country: Italy
facility: Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS
city: Monza
country: Italy
facility: Department of Cardiology, ASST Monza, San Gerardo Hospital
city: Padova
country: Italy
facility: Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova
city: Tricase
country: Italy
facility: Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT)
city: Zurich
country: Switzerland
facility: University Hospital Zurich,
Study officials:
affiliation: Luigi Sacco University Hospital
name: Giovanni B Forleo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Luigi Sacco University Hospital
name: Gianfranco MItacchione, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, Narasimhan C, Steinwender C, Brugada J, Lloyd M, Roberts PR, Sagi V, Hummel J, Bongiorni MG, Knops RE, Ellis CR, Gornick CC, Bernabei MA, Laager V, Stromberg K, Williams ER, Hudnall JH, Ritter P; Micra Transcatheter Pacing Study Group. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Feb 11;374(6):533-41. doi: 10.1056/NEJMoa1511643. Epub 2015 Nov 9.