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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

Tracking Information
First Submitted Date August 31, 2022
First Posted Date September 6, 2022
Last Update Posted Date December 23, 2022
Actual Study Start Date September 1, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2022)
  • All cause mortality [ Time Frame: through study completion, an average of 2 years ]
    overall mortality
  • Implant complication rates [ Time Frame: during and immediately after the intervention ]
    Dislodgments, Cardiac perforation, vascular complications (access site).
  • Electrical performance of the pacing system [ Time Frame: Through study completion, an average of 2 years ]
    Pacing thresholds
  • Electrical performance of the pacing system [ Time Frame: Through study completion, an average of 2 years ]
    R wave sensing
  • Electrical performance of the pacing system [ Time Frame: Through study completion, an average of 2 years ]
    pacing impedances values
  • Upgrading with a different pacing system [ Time Frame: Through study completion, an average of 2 years ]
    Need of an additional transvenous pacing system
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Ledless Pacemaker Registry
Official Title International Ledless Pacemaker Registry (i-LEAPER)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients in whom a MIcra was implanted for a cardiac bradyarrhythmia.
Condition
  • Block Complete Heart
  • Atrial Fibrillation
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 1, 2022)		 2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Giovanni B Forleo, MD, PhD 390239042789 forleo@me.com
Contact: Marco Schiavone, MD +390239042789 marco.schiavone11@gmail.com
Listed Location Countries Belgium,   Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT05528029
Other Study ID Numbers Hsacco2022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Giovanni B Forleo, Luigi Sacco University Hospital
Original Responsible Party Same as current
Current Study Sponsor Luigi Sacco University Hospital
Original Study Sponsor Same as current
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
Investigators
Principal Investigator: Giovanni B Forleo, MD, PhD Luigi Sacco University Hospital
Principal Investigator: Gianfranco MItacchione, MD, PhD Luigi Sacco University Hospital
PRS Account Luigi Sacco University Hospital
Verification Date December 2022