Clinical trial NCT04253184: Micra AV Transcatheter Pacing System Post-Approval Registry
Official title: Micra AV Transcatheter Pacing System Post-Approval Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bradycardia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 802
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intended to be implanted with a Micra AV system are eligible for enrollment and all patients must be consented prior to the implant. As such, only geographies with regulatory approval for the Micra system are eligible to enroll patients (see locations section).

All patients enrolled and successfully implanted with a Micra AV system will be followed for a minimum of 3 years, unless a patient is exited from the registry due to an unavoidable reason. If a Micra AV system is not successfully implanted, patients will be exited from the registry unless a Micra AV System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of pacemaker syndrome
timeFrame: After 3 years of Follow Up
Secondary outcomes:
measure: Acute complication rate
timeFrame: After 30 days of Follow Up
measure: Long-term complication rate
timeFrame: After 3 years of Follow up
Other outcomes:
measure: AV Synchrony Loss
timeFrame: After 3 years of Follow up
measure: System and Procedure Related Adverse Events
timeFrame: After 3 years of Follow up
measure: Implant Characteristics
timeFrame: Up to 3 years of Follow Up
measure: Electrical Performance
timeFrame: After 3 years of Follow up
measure: A4 Amplitude
timeFrame: After 3 years of Follow up
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Cardiology Center
state: California
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: New Haven
country: United States
facility: Yale New Haven Health System
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Research Institute
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute
state: Kansas
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare
state: Kentucky
city: Baltimore
country: United States
facility: The John Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: MedStar Baltimore
state: Maryland
city: Salisbury
country: United States
facility: TidalHealth Peninsula Regional Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Cardiology Consultants
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Hattiesburg
country: United States
facility: Forrest General Hospital
state: Mississippi
city: Kansas City
country: United States
facility: Saint Lukes Health System
state: Missouri
city: Ocean City
country: United States
facility: Monmouth Cardiology
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Erie
country: United States
facility: Medicor Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Shadyside
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Fort Worth
country: United States
facility: Consultants in Cardiology
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Leuven
country: Belgium
facility: UZ Leuven-Campus - Campus Gasthuisberg
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Calgary
country: Canada
facility: University of Calgary
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
city: Montréal
country: Canada
facility: Montreal Heart Institute
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours - Hopital trousseau
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: Jena
country: Germany
facility: Universitätsklinikum Jena - Friedrich Schiller Universität
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe GmbH
city: Köln
country: Germany
facility: St. Vinzenz-Hospital Köln
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus
city: Villingen-Schwenningen
country: Germany
facility: Klinikum Villingen-Schwenningen
city: Athens
country: Greece
facility: Hygeia Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center Ashkelon
city: Brescia
country: Italy
facility: Azienda Ospedaliera Sepdali Civili di Brescia
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Kuala Lumpur
country: Malaysia
facility: Cardiac Vascular Sentral Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Locatie AMC
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis - Locatie Leyweg
city: Oslo
country: Norway
facility: Akerhus University Hospital
city: Carnaxide
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
city: Riyadh
country: Saudi Arabia
facility: King Salman Heart Center - King Fahad Medical City
city: Belgrade
country: Serbia
facility: Klinicki Centar Srbije
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Coruña
country: Spain
facility: Hospital Universitario da Coruña
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
city: Bern
country: Switzerland
facility: Inselspital-Universitatsspital Bern
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
References: