International Ledless Pacemaker Registry

Atrial Fibrillation Clinical Trial

— i-LEAPER  

Official title:

International Ledless Pacemaker Registry (i-LEAPER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528029
• Other study ID #: Hsacco2022
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Luigi Sacco University Hospital
• Contact: Giovanni B Forleo, MD, PhD
• Phone: 390239042789
• Email: forleo[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Belgium	Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit	Brussels
Italy	Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona (IT)	Ancona
Italy	Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico Di S. Orsola	Bologna
Italy	Spedali Civili di Brescia	Brescia
Italy	Cardiology Unit, Vito Fazzi Hospital, Lecce (IT)	Lecce
Italy	Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS	Milano
Italy	Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"	Milano
Italy	Department of Clinical Electrophysiology and Cardiac Pacing, Centro Cardiologico Monzino, IRCSS	MIlano
Italy	Department of Cardiology, ASST Monza, San Gerardo Hospital	Monza
Italy	Departtment of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova	Padova
Italy	Cardiology Unit, "Card. G. Panico" Hospital, Tricase (IT)	Tricase
Switzerland	University Hospital Zurich,	Zurich

Sponsors (13)

Lead Sponsor

Collaborator

Luigi Sacco University Hospital

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

Countries where clinical trial is conducted

Belgium,  Italy,  Switzerland, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	overall mortality	through study completion, an average of 2 years
Primary	Implant complication rates	Dislodgments, Cardiac perforation, vascular complications (access site).	during and immediately after the intervention
Primary	Electrical performance of the pacing system	Pacing thresholds	Through study completion, an average of 2 years
Primary	Electrical performance of the pacing system	R wave sensing	Through study completion, an average of 2 years
Primary	Electrical performance of the pacing system	pacing impedances values	Through study completion, an average of 2 years
Primary	Upgrading with a different pacing system	Need of an additional transvenous pacing system	Through study completion, an average of 2 years