Micra AV Transcatheter Pacing System Post-Approval Registry (Micra AV PAS)

January 31, 2024 updated by: Medtronic

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

802

Contacts and Locations

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

Study Locations

  • Belgium
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel
      • Leuven, Belgium
        • UZ Leuven-Campus - Campus Gasthuisberg
      • Liège, Belgium
        • Centre Hospitalier Régional de la Citadelle
  • Canada
      • Calgary, Canada
        • University of Calgary
      • Montréal, Canada
        • Centre hospitalier de l'Université de Montréal (CHUM)
      • Montréal, Canada
        • Montreal Heart Institute
      • Québec, Canada
        • Institut Universitaire de Cardiologie et de Pneumologie de Québec
  • Czechia
      • Prague, Czechia
        • Na Homolce Hospital
  • Denmark
      • Odense, Denmark
        • Odense Universitetshospital
  • France
      • Chambray-lès-Tours, France
        • CHRU de Tours - Hôpital Trousseau
      • Clermont-Ferrand, France
        • Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied
      • Paris, France
        • Hopital Europeen Georges-Pompidou
      • Pessac, France
        • Hôpital Haut-Lévêque - CHU de Bordeaux
      • Toulouse, France
        • Clinique Pasteur
      • Toulouse, France
        • CHU Toulouse - Hôpital Rangueil
  • Germany
      • Jena, Germany
        • Universitätsklinikum Jena - Friedrich Schiller Universität
      • Karlsruhe, Germany
        • Städtisches Klinikum Karlsruhe GmbH
      • Köln, Germany
        • St. Vinzenz-Hospital Köln
      • Stuttgart, Germany
        • Robert Bosch Krankenhaus
      • Villingen-Schwenningen, Germany
        • Klinikum Villingen-Schwenningen
  • Greece
      • Athens, Greece
        • Hygeia Hospital
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center Ashkelon
  • Italy
      • Brescia, Italy
        • Azienda Ospedaliera Sepdali Civili di Brescia
      • Cotignola, Italy
        • Maria Cecilia Hospital
      • Milano, Italy
        • Centro Cardiologico Monzino
      • Pisa, Italy
        • Azienda Ospedaliero-Universitaria Pisana
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Jantung Negara
      • Kuala Lumpur, Malaysia
        • Cardiac Vascular Sentral Kuala Lumpur
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC - Locatie AMC
      • Den Haag, Netherlands
        • HagaZiekenhuis - Locatie Leyweg
  • Norway
      • Oslo, Norway
        • Akerhus University Hospital
  • Portugal
      • Carnaxide, Portugal
        • Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Salman Heart Center - King Fahad Medical City
  • Serbia
      • Belgrade, Serbia
        • Klinicki Centar Srbije
  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Centre Ljubljana
  • Spain
      • Barcelona, Spain
        • Hospital de la Santa Creu I Sant Pau
      • Coruña, Spain
        • Hospital Universitario da Coruña
      • Santiago De Compostela, Spain
        • Complejo Hospitalario Universitario de Santiago de Compostela
  • Switzerland
      • Bern, Switzerland
        • Inselspital-Universitatsspital Bern
      • Zürich, Switzerland
        • UniversitätsSpital Zürich
  • United Kingdom
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • Northampton, United Kingdom
        • Northampton General Hospital NHS Trust
      • Southampton, United Kingdom
        • Southampton General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The University of Alabama at Birmingham
    • California
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Desert Cardiology Center
      • Redwood City, California, United States, 94062
        • Sequoia Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale New Haven Health System
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Methodist Research Institute
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Healthcare
    • Maryland
      • Baltimore, Maryland, United States, 20817
        • The John Hopkins Hospital
      • Baltimore, Maryland, United States, 21204
        • MedStar Baltimore
      • Salisbury, Maryland, United States, 21804
        • TidalHealth Peninsula Regional Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Metropolitan Cardiology Consultants
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Heart & Vascular Center
      • Saint Paul, Minnesota, United States, 55102
        • United Heart and Vascular Clinic
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39404
        • Forrest General Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Lukes Health System
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Monmouth Cardiology
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10021
        • New York-Presbyterian Hospital/Weill Cornell Medical Center
      • New York, New York, United States, 10022
        • New York-Presbyterian Hospital/Columbia University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • The University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital Research Foundation
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Erie, Pennsylvania, United States, 16507
        • Medicor Associates
      • Philadelphia, Pennsylvania, United States, 19096
        • Lankenau Institute for Medical Research
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center UPMC Shadyside
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Fort Worth, Texas, United States, 76104
        • Consultants in Cardiology
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Cardiovascular Services

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 Micra system 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 such as death, physician discretion, or patient withdrawal of consent. 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.

Description

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

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pacemaker syndrome
Time Frame: 3 years
To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute complication rate
Time Frame: 30 days
To estimate the acute major complication rate related to the Micra AV system and/or procedure.
30 days
Long-term complication rate
Time Frame: 3 years
To estimate the 3-year major complication rate related to the Micra AV system and/or procedure.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AV Synchrony Loss
Time Frame: 3 years
To characterize the rate and severity of adverse events potentially related to AV synchrony loss
3 years
System and Procedure Related Adverse Events
Time Frame: 3 years
Summarize Micra AV system or procedure related adverse events
3 years
Implant Characteristics
Time Frame: Up to 3 years
Characterize the implant procedure
Up to 3 years
Electrical Performance
Time Frame: 3 years
Characterize electrical performance over time
3 years
A4 Amplitude
Time Frame: 3 years
Characterize A4 amplitude over time
3 years

Collaborators and Investigators

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

Sponsor

Medtronic

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)

February 8, 2020

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Micra AV PAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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