Micra AV Transcatheter Pacing System Post-Approval Registry

Bradycardia Clinical Trial

— Micra AV PAS  

Official title:

Micra AV Transcatheter Pacing System Post-Approval Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04253184
• Other study ID #: Micra AV PAS
• Status: Active, not recruiting
• Start date: February 8, 2020
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release.

The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

Description:

The Micra AV Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra AV Registry will be prospectively followed for a minimum of 3 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent).

Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra AV system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's routine clinical care practice, those visits are reported. The total estimated registry duration is 4.5 years

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 802
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

• Patient is intended to receive or be treated with a Micra AV Transcatheter Pacing System and must be enrolled prior to the implant procedure

Exclusion Criteria:

• Patient who is, or is expected to be inaccessible for follow-up

• Patient with exclusion criteria required by local law

• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Related Conditions & MeSH terms

• Bradycardia

Intervention

Drug:
• Micra AV Transcatheter Pacing System
The Micra AV Transcatheter Pacing System (TPS) is a miniaturized single chamber pacemaker that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart to provide bipolar sensing and pacing. The Micra AV system provides a form of VDD pacing that is based on mechanical atrial sensing utilizing a 3-axis accelerometer.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	UZ Leuven-Campus - Campus Gasthuisberg	Leuven
Belgium	Centre Hospitalier Régional de la Citadelle	Liège
Canada	University of Calgary	Calgary
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montréal
Canada	Montreal Heart Institute	Montréal
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Québec
Czechia	Na Homolce Hospital	Prague
Denmark	Odense Universitetshospital	Odense
France	CHRU de Tours - Hopital trousseau	Chambray-lès-Tours
France	Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied	Clermont-Ferrand
France	Hôpital Européen Georges-Pompidou	Paris
France	Hôpital Haut-Lévêque - CHU de Bordeaux	Pessac
France	CHU Toulouse - Hôpital Rangueil	Toulouse
France	Clinique Pasteur	Toulouse
Germany	Universitätsklinikum Jena - Friedrich Schiller Universität	Jena
Germany	Städtisches Klinikum Karlsruhe GmbH	Karlsruhe
Germany	St. Vinzenz-Hospital Köln	Köln
Germany	Robert Bosch Krankenhaus	Stuttgart
Germany	Klinikum Villingen-Schwenningen	Villingen-Schwenningen
Greece	Hygeia Hospital	Athens
Israel	Barzilai Medical Center Ashkelon	Ashkelon
Italy	Azienda Ospedaliera Sepdali Civili di Brescia	Brescia
Italy	Maria Cecilia Hospital	Cotignola
Italy	Centro Cardiologico Monzino	Milano
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Malaysia	Cardiac Vascular Sentral Kuala Lumpur	Kuala Lumpur
Malaysia	Institut Jantung Negara	Kuala Lumpur
Netherlands	Amsterdam UMC - Locatie AMC	Amsterdam
Netherlands	HagaZiekenhuis - Locatie Leyweg	Den Haag
Norway	Akerhus University Hospital	Oslo
Portugal	Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz	Carnaxide
Saudi Arabia	King Salman Heart Center - King Fahad Medical City	Riyadh
Serbia	Klinicki Centar Srbije	Belgrade
Slovenia	University Medical Centre Ljubljana	Ljubljana
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitario da Coruña	Coruña
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago De Compostela
Switzerland	Inselspital-Universitatsspital Bern	Bern
Switzerland	UniversitätsSpital Zürich	Zürich
United Kingdom	Liverpool Heart and Chest Hospital NHS Foundation Trust	Liverpool
United Kingdom	Northampton General Hospital NHS Trust	Northampton
United Kingdom	Southampton General Hospital	Southampton
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Emory University Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	MedStar Baltimore	Baltimore	Maryland
United States	The John Hopkins Hospital	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Metropolitan Cardiology Consultants	Coon Rapids	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Saint Elizabeth Healthcare	Edgewood	Kentucky
United States	Medicor Associates	Erie	Pennsylvania
United States	Consultants in Cardiology	Fort Worth	Texas
United States	Forrest General Hospital	Hattiesburg	Mississippi
United States	Indiana University Health Methodist Research Institute	Indianapolis	Indiana
United States	Baptist Health	Jacksonville	Florida
United States	Saint Lukes Health System	Kansas City	Missouri
United States	University of Kansas Medical Center Research Institute	Kansas City	Kansas
United States	Northwell Health	Manhasset	New York
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Health System	New Haven	Connecticut
United States	New York-Presbyterian Hospital/Columbia University Medical Center	New York	New York
United States	New York-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Monmouth Cardiology	Ocean City	New Jersey
United States	Oklahoma Heart Hospital Research Foundation	Oklahoma City	Oklahoma
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Lankenau Institute for Medical Research	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center UPMC Shadyside	Pittsburgh	Pennsylvania
United States	WakeMed Health & Hospitals	Raleigh	North Carolina
United States	Eisenhower Desert Cardiology Center	Rancho Mirage	California
United States	Sequoia Hospital	Redwood City	California
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Mayo Clinic	Rochester	Minnesota
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota
United States	United Heart and Vascular Clinic	Saint Paul	Minnesota
United States	TidalHealth Peninsula Regional Medical Center	Salisbury	Maryland
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Malaysia,  Netherlands,  Norway,  Portugal,  Saudi Arabia,  Serbia,  Slovenia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AV Synchrony Loss	To characterize the rate and severity of adverse events potentially related to AV synchrony loss	3 years
Other	System and Procedure Related Adverse Events	Summarize Micra AV system or procedure related adverse events	3 years
Other	Implant Characteristics	Characterize the implant procedure	Up to 3 years
Other	Electrical Performance	Characterize electrical performance over time	3 years
Other	A4 Amplitude	Characterize A4 amplitude over time	3 years
Primary	Rate of pacemaker syndrome	To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.	3 years
Secondary	Acute complication rate	To estimate the acute major complication rate related to the Micra AV system and/or procedure.	30 days
Secondary	Long-term complication rate	To estimate the 3-year major complication rate related to the Micra AV system and/or procedure.	3 years