Micra AV Transcatheter Pacing System Post-Approval Registry
- Conditions
- Bradycardia
- Registration Number
- NCT04253184
- Lead Sponsor
- Medtronic
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 802
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of pacemaker syndrome After 3 years of Follow Up To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.
- Secondary Outcome Measures
Name Time Method Acute complication rate After 30 days of Follow Up To estimate the acute major complication rate related to the Micra AV system and/or procedure.
Long-term complication rate After 3 years of Follow up To estimate the 3-year major complication rate related to the Micra AV system and/or procedure.
Trial Locations
- Locations (89)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
The John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
MedStar Baltimore
🇺🇸Baltimore, Maryland, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Kansas Medical Center Research Institute
🇺🇸Kansas City, Kansas, United States
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium
UZ Leuven-Campus - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Centre Hospitalier Régional de la Citadelle
🇧🇪Liège, Belgium
Akerhus University Hospital
🇳🇴Oslo, Norway
Saint Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
🇺🇸New York, New York, United States
New York-Presbyterian Hospital/Columbia University Medical Center
🇺🇸New York, New York, 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
Baptist Health
🇺🇸Jacksonville, Florida, United States
TidalHealth Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Metropolitan Cardiology Consultants
🇺🇸Coon Rapids, Minnesota, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
CentraCare Heart & Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Forrest General Hospital
🇺🇸Hattiesburg, Mississippi, United States
United Heart and Vascular Clinic
🇺🇸Saint Paul, Minnesota, United States
Monmouth Cardiology
🇺🇸Ocean City, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Maria Cecilia Hospital
🇮🇹Cotignola, Italy
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Lankenau Institute for Medical Research
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Consultants in Cardiology
🇺🇸Fort Worth, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Centre Hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montréal, Canada
University of Calgary
🇨🇦Calgary, Canada
Montreal Heart Institute
🇨🇦Montréal, Canada
Odense Universitetshospital
🇩🇰Odense, Denmark
CHRU de Tours - Hopital trousseau
🇫🇷Chambray-lès-Tours, France
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Québec, Canada
Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied
🇫🇷Clermont-Ferrand, France
Universitätsklinikum Jena - Friedrich Schiller Universität
🇩🇪Jena, Germany
Hôpital Européen Georges-Pompidou
🇫🇷Paris, France
Hôpital Haut-Lévêque - CHU de Bordeaux
🇫🇷Pessac, France
CHU Toulouse - Hôpital Rangueil
🇫🇷Toulouse, France
Clinique Pasteur
🇫🇷Toulouse, France
Städtisches Klinikum Karlsruhe GmbH
🇩🇪Karlsruhe, Germany
Hygeia Hospital
🇬🇷Athens, Greece
Klinikum Villingen-Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Robert Bosch Krankenhaus
🇩🇪Stuttgart, Germany
Azienda Ospedaliera Sepdali Civili di Brescia
🇮🇹Brescia, Italy
Barzilai Medical Center Ashkelon
🇮🇱Ashkelon, Israel
Cardiac Vascular Sentral Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
Amsterdam UMC - Locatie AMC
🇳🇱Amsterdam, Netherlands
Institut Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
HagaZiekenhuis - Locatie Leyweg
🇳🇱Den Haag, Netherlands
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
🇵🇹Carnaxide, Portugal
King Salman Heart Center - King Fahad Medical City
🇸🇦Riyadh, Saudi Arabia
University Medical Centre Ljubljana
🇸🇮Ljubljana, Slovenia
Hospital Universitario da Coruña
🇪🇸Coruña, Spain
Klinicki Centar Srbije
🇷🇸Belgrade, Serbia
Hospital de la Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
Inselspital-Universitatsspital Bern
🇨🇭Bern, Switzerland
UniversitätsSpital Zürich
🇨🇭Zürich, Switzerland
Liverpool Heart and Chest Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Northampton General Hospital NHS Trust
🇬🇧Northampton, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Na Homolce Hospital
🇨🇿Prague, Czechia
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Medicor Associates
🇺🇸Erie, Pennsylvania, United States
Indiana University Health Methodist Research Institute
🇺🇸Indianapolis, Indiana, United States
St. Vinzenz-Hospital Köln
🇩🇪Köln, Germany
Northwell Health
🇺🇸Manhasset, New York, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Yale New Haven Health System
🇺🇸New Haven, Connecticut, United States
Aurora Cardiovascular Services
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Saint Lukes Health System
🇺🇸Kansas City, Missouri, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Oklahoma Heart Hospital Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States