International Ledless Pacemaker Registry (i-LEAPER)

December 21, 2022 updated by: Giovanni B Forleo, Luigi Sacco University Hospital

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

Recruiting

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

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Giovanni B Forleo, MD, PhD
  • Phone Number: 390239042789
  • Email: forleo@me.com

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium
        • Recruiting
        • Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit
        • Contact:
        • Principal Investigator:
          • Gianbattista Chierchia, MD
  • Italy
      • Ancona, Italy
        • Recruiting
        • Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT)
        • Contact:
        • Principal Investigator:
          • Antonio Dello Russo, MD
      • Bologna, Italy
        • Recruiting
        • Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola
        • Contact:
        • Principal Investigator:
          • Mauro Biffi, MD
      • Brescia, Italy, 25123
        • Recruiting
        • Spedali Civili di Brescia
      • Lecce, Italy
        • Recruiting
        • Cardiology Unit, Vito Fazzi Hospital, Lecce (IT)
        • Contact:
        • Principal Investigator:
          • Ennio Pisanò, MD
      • MIlano, Italy
        • Recruiting
        • Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS
        • Contact:
        • Principal Investigator:
          • Claudio Tondo, MD, PhD
      • Milano, Italy
        • Recruiting
        • Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS
        • Contact:
        • Principal Investigator:
          • Simone Gulletta, MD
      • Milano, Italy
        • Recruiting
        • Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
        • Principal Investigator:
          • Gianfranco MItacchione, MD, PhD
        • Contact:
          • Giovanni Battista Forleo, MD, PhD
          • Phone Number: +39 0239042789
          • Email: forleo@me.com
        • Principal Investigator:
          • Giovanni Forleo, MD, PhD
      • Monza, Italy
        • Recruiting
        • Department of Cardiology, ASST Monza, San Gerardo Hospital
        • Contact:
        • Principal Investigator:
          • Giovanni Rovaris, MD
      • Padova, Italy
        • Recruiting
        • Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova
        • Contact:
      • Tricase, Italy
        • Recruiting
        • Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT)
        • Principal Investigator:
          • Pietro Palmisano, MD
  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • University Hospital Zurich,
        • Contact:
        • Principal Investigator:
          • Ardan M Sagunder, MD
        • Principal Investigator:
          • Daniel Hofner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients in whom a MIcra was implanted for a cardiac bradyarrhythmia.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Luigi Sacco University Hospital

Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
University of Padova
Università degli Studi di Ferrara
Universitair Ziekenhuis Brussel
University Hospital, Zürich
Università degli Studi di Brescia
Azienda Ospedaliera San Gerardo di Monza
Centro Cardiologico Monzino
Azienda Ospedaliera Cardinale G. Panico
San Raffaele University Hospital, Italy
Ospedali Riuniti Ancona
Ospedale V. Fazzi

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Estimate)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

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)?

Undecided

Drug and device information, study documents

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

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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