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| Name | Class |
|---|---|
| Università degli Studi di Brescia | OTHER |
| Centro Cardiologico Monzino | OTHER |
| University Hospital, Zürich | OTHER |
| Azienda Ospedaliera Cardinale G. Panico |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leadless Pacemaker (Micra) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | overall mortality | through study completion, an average of 2 years |
| Implant complication rates | Dislodgments, Cardiac perforation, vascular complications (access site). | during and immediately after the intervention |
| Electrical performance of the pacing system | Pacing thresholds | Through study completion, an average of 2 years |
| Electrical performance of the pacing system | R wave sensing | Through study completion, an average of 2 years |
| Electrical performance of the pacing system | pacing impedances values | Through study completion, an average of 2 years |
| Upgrading with a different pacing system | Need of an additional transvenous pacing system | Through study completion, an average of 2 years |
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Inclusion Criteria: All patients implanted with the MIcra leadless pacing system
Exclusion Criteria:
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Patients in whom a MIcra was implanted for a cardiac bradyarrhythmia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni B Forleo, MD, PhD | Contact | 390239042789 | forleo@me.com | |
| Marco Schiavone, MD | Contact | +390239042789 | marco.schiavone11@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni B Forleo, MD, PhD | Luigi Sacco University Hospital | Principal Investigator |
| Gianfranco MItacchione, MD, PhD | Luigi Sacco University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit | Recruiting | Brussels | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26551877 | Result | 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. | |
| 37481220 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| OTHER |
| Azienda Ospedaliera San Gerardo di Monza | OTHER |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
| San Raffaele University Hospital, Italy | OTHER |
| Ospedale V. Fazzi | OTHER |
| Ospedali Riuniti Ancona | OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
| Università degli Studi di Ferrara | OTHER |
| University of Padova | OTHER |
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|
| Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT) | Recruiting | Ancona | Italy |
|
| Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola | Recruiting | Bologna | Italy |
|
| Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
|
| Cardiology Unit, Vito Fazzi Hospital, Lecce (IT) | Recruiting | Lecce | Italy |
|
| Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS | Recruiting | Milan | Italy |
|
| Azienda Ospedaliera - Polo Universitario - "Luigi Sacco" | Recruiting | Milan | Italy |
|
| Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS | Recruiting | Milan | Italy |
|
| Department of Cardiology, ASST Monza, San Gerardo Hospital | Recruiting | Monza | Italy |
|
| Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova | Recruiting | Padova | Italy |
|
| Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT) | Recruiting | Tricase | Italy |
|
| University Hospital Zurich, | Recruiting | Zurich | Switzerland |
|
| Derived |
| Mitacchione G, Schiavone M, Gasperetti A, Arabia G, Tundo F, Breitenstein A, Montemerlo E, Monaco C, Gulletta S, Palmisano P, Hofer D, Rovaris G, Dello Russo A, Biffi M, Pisano ECL, Della Bella P, Di Biase L, Chierchia GB, Saguner AM, Tondo C, Curnis A, Forleo GB. Sex differences in leadless pacemaker implantation: A propensity-matched analysis from the i-LEAPER registry. Heart Rhythm. 2023 Oct;20(10):1429-1435. doi: 10.1016/j.hrthm.2023.07.061. Epub 2023 Jul 20. |
| 36496135 | Derived | Mitacchione G, Schiavone M, Gasperetti A, Arabia G, Breitenstein A, Cerini M, Palmisano P, Montemerlo E, Ziacchi M, Gulletta S, Salghetti F, Russo G, Monaco C, Mazzone P, Hofer D, Tundo F, Rovaris G, Russo AD, Biffi M, Pisano ECL, Chierchia GB, Della Bella P, de Asmundis C, Saguner AM, Tondo C, Forleo GB, Curnis A. Outcomes of leadless pacemaker implantation following transvenous lead extraction in high-volume referral centers: Real-world data from a large international registry. Heart Rhythm. 2023 Mar;20(3):395-404. doi: 10.1016/j.hrthm.2022.12.002. Epub 2022 Dec 7. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |