Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2022-09-01
2024-12-31
Brief Summary
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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
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Baselines characteristics, procedural and clinical outcomes will be collected and analyzed.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Leadless 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.
Eligibility Criteria
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Inclusion Criteria
* At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Università degli Studi di Brescia
OTHER
Centro Cardiologico Monzino
OTHER
University Hospital, Zürich
OTHER
Azienda Ospedaliera Cardinale G. Panico
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
Luigi Sacco University Hospital
OTHER
Responsible Party
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Giovanni B Forleo
Section Head Electrophysiology and Clinical Pacing
Principal Investigators
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Giovanni B Forleo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Luigi Sacco University Hospital
Gianfranco MItacchione, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Luigi Sacco University Hospital
Locations
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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
Spedali Civili di Brescia
Brescia, , Italy
Cardiology Unit, Vito Fazzi Hospital, Lecce (IT)
Lecce, , Italy
Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS
Milan, , Italy
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
Milan, , Italy
Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS
Milan, , Italy
Department of Cardiology, ASST Monza, San Gerardo Hospital
Monza, , Italy
Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova
Padua, , Italy
Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT)
Tricase, , Italy
University Hospital Zurich,
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Carlo De Asmundis, MD
Role: primary
Antonio Dello Russo, MD, PhD
Role: primary
Mauro Biffi, MD
Role: primary
Antonio Curnis, MD
Role: primary
Ennio Pisanò, MD
Role: primary
Simone Gulletta, MD
Role: primary
Giovanni Battista Forleo, MD, PhD
Role: primary
Claudio Tondo, MD, PhD
Role: primary
Giovanni Rovaris, MD
Role: primary
Federico Migliore, MD
Role: primary
Pietro Palmisano, MD
Role: primary
Ardan M Sagunder, MD
Role: primary
References
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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.
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.
Other Identifiers
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Hsacco2022
Identifier Type: -
Identifier Source: org_study_id