- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05528029
International Ledless Pacemaker Registry (i-LEAPER)
International Ledless Pacemaker Registry (i-LEAPER)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Giovanni B Forleo, MD, PhD
- Phone Number: 390239042789
- Email: forleo@me.com
Study Contact Backup
- Name: Marco Schiavone, MD
- Phone Number: +390239042789
- Email: marco.schiavone11@gmail.com
Study Locations
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Brussels, Belgium
- Recruiting
- Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit
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Contact:
- Carlo De Asmundis, MD
- Email: Carlo.DeAsmundis@uzbrussel.be
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Principal Investigator:
- Gianbattista Chierchia, MD
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Ancona, Italy
- Recruiting
- Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT)
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Contact:
- Antonio Dello Russo, MD, PhD
- Email: antonio.dellorusso@gmail.com
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Principal Investigator:
- Antonio Dello Russo, MD
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Bologna, Italy
- Recruiting
- Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola
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Contact:
- Mauro Biffi, MD
- Email: mbiffi64@gmail.com
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Principal Investigator:
- Mauro Biffi, MD
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Brescia, Italy, 25123
- Recruiting
- Spedali Civili di Brescia
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Lecce, Italy
- Recruiting
- Cardiology Unit, Vito Fazzi Hospital, Lecce (IT)
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Contact:
- Ennio Pisanò, MD
- Email: enniopisano@hotmail.com
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Principal Investigator:
- Ennio Pisanò, MD
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MIlano, Italy
- Recruiting
- Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS
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Contact:
- Claudio Tondo, MD, PhD
- Email: claudio.tondo@cardiologicomonzino.it
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Principal Investigator:
- Claudio Tondo, MD, PhD
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Milano, Italy
- Recruiting
- Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS
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Contact:
- Simone Gulletta, MD
- Email: gulletta.simone@hsr.it
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Principal Investigator:
- Simone Gulletta, MD
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Milano, Italy
- Recruiting
- Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
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Principal Investigator:
- Gianfranco MItacchione, MD, PhD
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Contact:
- Giovanni Battista Forleo, MD, PhD
- Phone Number: +39 0239042789
- Email: forleo@me.com
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Principal Investigator:
- Giovanni Forleo, MD, PhD
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Monza, Italy
- Recruiting
- Department of Cardiology, ASST Monza, San Gerardo Hospital
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Contact:
- Giovanni Rovaris, MD
- Email: rovaris.gi@gmail.com
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Principal Investigator:
- Giovanni Rovaris, MD
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Padova, Italy
- Recruiting
- Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova
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Contact:
- Federico Migliore, MD
- Phone Number: +39 0498212311
- Email: federico.migliore@unipd.it
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Tricase, Italy
- Recruiting
- Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT)
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Principal Investigator:
- Pietro Palmisano, MD
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Zurich, Switzerland
- Recruiting
- University Hospital Zurich,
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Contact:
- Ardan M Sagunder, MD
- Email: ardan.sagunder@usz.ch
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Principal Investigator:
- Ardan M Sagunder, MD
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Principal Investigator:
- Daniel Hofner, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cause mortality
Time Frame: through study completion, an average of 2 years
|
overall mortality
|
through study completion, an average of 2 years
|
Implant complication rates
Time Frame: during and immediately after the intervention
|
Dislodgments, Cardiac perforation, vascular complications (access site).
|
during and immediately after the intervention
|
Electrical performance of the pacing system
Time Frame: Through study completion, an average of 2 years
|
Pacing thresholds
|
Through study completion, an average of 2 years
|
Electrical performance of the pacing system
Time Frame: Through study completion, an average of 2 years
|
R wave sensing
|
Through study completion, an average of 2 years
|
Electrical performance of the pacing system
Time Frame: Through study completion, an average of 2 years
|
pacing impedances values
|
Through study completion, an average of 2 years
|
Upgrading with a different pacing system
Time Frame: Through study completion, an average of 2 years
|
Need of an additional transvenous pacing system
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Giovanni B Forleo, MD, PhD, Luigi Sacco University Hospital
- Principal Investigator: Gianfranco MItacchione, MD, PhD, Luigi Sacco University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hsacco2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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