This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

International Ledless Pacemaker Registry (i-LEAPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05528029
Recruitment Status : Recruiting
First Posted : September 6, 2022
Last Update Posted : December 23, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Giovanni B Forleo, Luigi Sacco University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Block Complete Heart Atrial Fibrillation Device: Leadless Pacemaker (Micra)

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: International Ledless Pacemaker Registry (i-LEAPER)
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: 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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. All cause mortality [ Time Frame: through study completion, an average of 2 years ]
    overall mortality

  2. Implant complication rates [ Time Frame: during and immediately after the intervention ]
    Dislodgments, Cardiac perforation, vascular complications (access site).

  3. Electrical performance of the pacing system [ Time Frame: Through study completion, an average of 2 years ]
    Pacing thresholds

  4. Electrical performance of the pacing system [ Time Frame: Through study completion, an average of 2 years ]
    R wave sensing

  5. Electrical performance of the pacing system [ Time Frame: Through study completion, an average of 2 years ]
    pacing impedances values

  6. Upgrading with a different pacing system [ Time Frame: Through study completion, an average of 2 years ]
    Need of an additional transvenous pacing system


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in whom a MIcra was implanted for a cardiac bradyarrhythmia.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05528029


Contacts
Layout table for location contacts
Contact: Giovanni B Forleo, MD, PhD 390239042789 forleo@me.com
Contact: Marco Schiavone, MD +390239042789 marco.schiavone11@gmail.com

Locations
Layout table for location information
Belgium
Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit Recruiting
Brussels, Belgium
Contact: Carlo De Asmundis, MD       Carlo.DeAsmundis@uzbrussel.be   
Principal Investigator: Carlo De Asmundis, MD         
Principal Investigator: Gianbattista Chierchia, MD         
Italy
Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT) Recruiting
Ancona, Italy
Contact: Antonio Dello Russo, MD, PhD       antonio.dellorusso@gmail.com   
Principal Investigator: Antonio Dello Russo, MD         
Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola Recruiting
Bologna, Italy
Contact: Mauro Biffi, MD       mbiffi64@gmail.com   
Principal Investigator: Mauro Biffi, MD         
Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Antonio Curnis, MD    +390303995552    antonio.curnis@unibs.it   
Cardiology Unit, Vito Fazzi Hospital, Lecce (IT) Recruiting
Lecce, Italy
Contact: Ennio Pisanò, MD       enniopisano@hotmail.com   
Principal Investigator: Ennio Pisanò, MD         
Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS Recruiting
Milano, Italy
Contact: Simone Gulletta, MD       gulletta.simone@hsr.it   
Principal Investigator: Simone Gulletta, MD         
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco" Recruiting
Milano, Italy
Contact: Giovanni Battista Forleo, MD, PhD    0239042789 ext +39    forleo@me.com   
Principal Investigator: Giovanni Forleo, MD, PhD         
Principal Investigator: Gianfranco MItacchione, MD, PhD         
Sub-Investigator: Alessio Gasperetti, MD         
Sub-Investigator: Marco Schiavone, MD         
Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS Recruiting
MIlano, Italy
Contact: Claudio Tondo, MD, PhD       claudio.tondo@cardiologicomonzino.it   
Principal Investigator: Claudio Tondo, MD, PhD         
Department of Cardiology, ASST Monza, San Gerardo Hospital Recruiting
Monza, Italy
Contact: Giovanni Rovaris, MD       rovaris.gi@gmail.com   
Principal Investigator: Giovanni Rovaris, MD         
Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova Recruiting
Padova, Italy
Contact: Federico Migliore, MD    0498212311 ext +39    federico.migliore@unipd.it   
Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT) Recruiting
Tricase, Italy
Contact: Pietro Palmisano, MD       dr.palmisano@libero.it   
Principal Investigator: Pietro Palmisano, MD         
Switzerland
University Hospital Zurich, Recruiting
Zurich, Switzerland
Contact: Ardan M Sagunder, MD       ardan.sagunder@usz.ch   
Principal Investigator: Ardan M Sagunder, MD         
Principal Investigator: Daniel Hofner, MD         
Sponsors and Collaborators
Luigi Sacco University Hospital
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
Investigators
Layout table for investigator information
Principal Investigator: Giovanni B Forleo, MD, PhD Luigi Sacco University Hospital
Principal Investigator: Gianfranco MItacchione, MD, PhD Luigi Sacco University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Giovanni B Forleo, Section Head Electrophysiology and Clinical Pacing, Luigi Sacco University Hospital
ClinicalTrials.gov Identifier: NCT05528029    
Other Study ID Numbers: Hsacco2022
First Posted: September 6, 2022    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Giovanni B Forleo, Luigi Sacco University Hospital:
leadless pacing
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes