Atrial Fibrillation, Block Complete Heart
Conditions
Keywords
leadless pacing
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.
Interventions
DEVICELeadless 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.
Sponsors
Università degli Studi di Brescia
Centro Cardiologico Monzino
University Hospital, Zürich
Azienda Ospedaliera Cardinale G. Panico
Azienda Ospedaliera San Gerardo di Monza
IRCCS Azienda Ospedaliero-Universitaria di Bologna
San Raffaele University Hospital, Italy
Ospedale V. Fazzi
Ospedali Riuniti Ancona
Universitair Ziekenhuis Brussel
Università degli Studi di Ferrara
University of Padova
Luigi Sacco University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | through study completion, an average of 2 years | overall mortality |
| Implant complication rates | during and immediately after the intervention | Dislodgments, Cardiac perforation, vascular complications (access site). |
| Electrical performance of the pacing system | Through study completion, an average of 2 years | Pacing thresholds |
| Upgrading with a different pacing system | Through study completion, an average of 2 years | Need of an additional transvenous pacing system |
Countries
Belgium, Italy, Switzerland
Contacts
Primary ContactGiovanni B Forleo, MD, PhD
Backup ContactMarco Schiavone, MD
Outcome results
None listed