International Ledless Pacemaker Registry

Recruiting

• Conditions: Block Complete Heart; Atrial Fibrillation

• Registration Number: NCT05528029
• Lead Sponsor: Luigi Sacco University Hospital

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.

Study Timeline

• Study First Submitted: 2022-08-31
• Study Start: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Upgrading with a different pacing system	Through study completion, an average of 2 years	Need of an additional transvenous pacing system
All cause mortality	through study completion, an average of 2 years	overall mortality
Electrical performance of the pacing system	Through study completion, an average of 2 years	pacing impedances values
Implant complication rates	during and immediately after the intervention	Dislodgments, Cardiac perforation, vascular complications (access site).

Trial Locations

Locations (12)

University Hospital Zurich,; 🇨🇭 Zurich, Switzerland

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"; 🇮🇹 Milano, Italy

Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit; 🇧🇪 Brussels, Belgium

Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT); 🇮🇹 Ancona, Italy

Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola; 🇮🇹 Bologna, Italy

Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS; 🇮🇹 Milano, Italy

Cardiology Unit, Vito Fazzi Hospital, Lecce (IT); 🇮🇹 Lecce, Italy

Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS; 🇮🇹 MIlano, Italy

Department of Cardiology, ASST Monza, San Gerardo Hospital; 🇮🇹 Monza, Italy

Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT); 🇮🇹 Tricase, Italy

Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova; 🇮🇹 Padova, Italy