International Ledless Pacemaker Registry

NCT05528029 | Unknown DMC FDA Device

• 1 other identifier: Hsacco2022
• Study Type: observational
• Target: 2,000
• Locations: 3 countries
• Sites: 12

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.

Conditions

Block Complete Heart; Atrial Fibrillation

Keywords

leadless pacing

Outcome Measures

Primary Outcomes (6)

• All cause mortality

  overall mortality

  through study completion, an average of 2 years

• Implant complication rates

  Dislodgments, Cardiac perforation, vascular complications (access site).

  during and immediately after the intervention

• Electrical performance of the pacing system

  Pacing thresholds

  Through study completion, an average of 2 years

• Electrical performance of the pacing system

  R wave sensing

  Through study completion, an average of 2 years

• Electrical performance of the pacing system

  pacing impedances values

  Through study completion, an average of 2 years

• Upgrading with a different pacing system

  Need of an additional transvenous pacing system

  Through study completion, an average of 2 years

Interventions

Leadless Pacemaker (Micra) DEVICE

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

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• At least 1 month of follow up
• At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (12)

Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit

Brussels, Belgium

RECRUITING

Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT)

Ancona, Italy

RECRUITING

Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola

Bologna, Italy

RECRUITING

Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Cardiology Unit, Vito Fazzi Hospital, Lecce (IT)

Lecce, Italy

RECRUITING

Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS

Milan, Italy

RECRUITING

Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"

Milan, Italy

RECRUITING

Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS

Milan, Italy

RECRUITING

Department of Cardiology, ASST Monza, San Gerardo Hospital

Monza, Italy

RECRUITING

Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova

Padua, Italy

RECRUITING

Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT)

Tricase, Italy

RECRUITING

University Hospital Zurich,

Zurich, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 26551877 RESULT

• 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.

  PMID: 36496135 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni B Forleo, MD, PhD

  Luigi Sacco University Hospital

  PRINCIPAL INVESTIGATOR

• Gianfranco MItacchione, MD, PhD

  Luigi Sacco University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni B Forleo, MD, PhD

CONTACT

390239042789; forleo@me.com

Marco Schiavone, MD

CONTACT

+390239042789; marco.schiavone11@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head Electrophysiology and Clinical Pacing

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 6, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

BE (1); IT (10); CH (1)