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.
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 Type
OBSERVATIONAL
Enrollment
2,000
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.
Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit
Brussels, Belgium
RECRUITINGCardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT)
All cause mortality
overall mortality
Time frame: through study completion, an average of 2 years
Implant complication rates
Dislodgments, Cardiac perforation, vascular complications (access site).
Time frame: during and immediately after the intervention
Electrical performance of the pacing system
Pacing thresholds
Time frame: Through study completion, an average of 2 years
Electrical performance of the pacing system
R wave sensing
Time frame: Through study completion, an average of 2 years
Electrical performance of the pacing system
pacing impedances values
Time frame: Through study completion, an average of 2 years
Upgrading with a different pacing system
Need of an additional transvenous pacing system
Time frame: Through study completion, an average of 2 years
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Ancona, Italy
Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola
Bologna, Italy
RECRUITINGSpedali Civili di Brescia
Brescia, Italy
RECRUITINGCardiology Unit, Vito Fazzi Hospital, Lecce (IT)
Lecce, Italy
RECRUITINGArrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS
Milan, Italy
RECRUITINGAzienda Ospedaliera - Polo Universitario - "Luigi Sacco"
Milan, Italy
RECRUITINGDepartment of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS
Milan, Italy
RECRUITINGDepartment of Cardiology, ASST Monza, San Gerardo Hospital
Monza, Italy
RECRUITINGDeparttment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova
Padua, Italy
RECRUITING...and 2 more locations