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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micra AV Transcatheter Pacing System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of pacemaker syndrome | To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant. | After 3 years of Follow Up |
| Measure | Description | Time Frame |
|---|---|---|
| Acute complication rate | To estimate the acute major complication rate related to the Micra AV system and/or procedure. | After 30 days of Follow Up |
| Long-term complication rate | To estimate the 3-year major complication rate related to the Micra AV system and/or procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| AV Synchrony Loss | To characterize the rate and severity of adverse events potentially related to AV synchrony loss | After 3 years of Follow up |
| System and Procedure Related Adverse Events | Summarize Micra AV system or procedure related adverse events |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Eisenhower Desert Cardiology Center |
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| After 3 years of Follow up |
| After 3 years of Follow up |
| Implant Characteristics | Characterize the implant procedure | Up to 3 years of Follow Up |
| Electrical Performance | Characterize electrical performance over time | After 3 years of Follow up |
| A4 Amplitude | Characterize A4 amplitude over time | After 3 years of Follow up |
| Rancho Mirage |
| California |
| 92270 |
| United States |
| Sequoia Hospital | Redwood City | California | 94062 | United States |
| Yale New Haven Health System | New Haven | Connecticut | 06520 | United States |
| Baptist Health | Jacksonville | Florida | 32207 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Indiana University Health Methodist Research Institute | Indianapolis | Indiana | 46202 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| Saint Elizabeth Healthcare | Edgewood | Kentucky | 41017 | United States |
| The John Hopkins Hospital | Baltimore | Maryland | 20817 | United States |
| MedStar Baltimore | Baltimore | Maryland | 21204 | United States |
| TidalHealth Peninsula Regional Medical Center | Salisbury | Maryland | 21804 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Metropolitan Cardiology Consultants | Coon Rapids | Minnesota | 55433 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | 56303 | United States |
| United Heart and Vascular Clinic | Saint Paul | Minnesota | 55102 | United States |
| Forrest General Hospital | Hattiesburg | Mississippi | 39404 | United States |
| Saint Lukes Health System | Kansas City | Missouri | 64111 | United States |
| Monmouth Cardiology | Ocean City | New Jersey | 07712 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| New York-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10021 | United States |
| New York-Presbyterian Hospital/Columbia University Medical Center | New York | New York | 10022 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma Heart Hospital Research Foundation | Oklahoma City | Oklahoma | 73120 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Medicor Associates | Erie | Pennsylvania | 16507 | United States |
| Lankenau Institute for Medical Research | Philadelphia | Pennsylvania | 19096 | United States |
| University of Pittsburgh Medical Center UPMC Shadyside | Pittsburgh | Pennsylvania | 15213 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Consultants in Cardiology | Fort Worth | Texas | 76104 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215 | United States |
| Universitair Ziekenhuis Brussel | Brussels | Belgium |
| UZ Leuven-Campus - Campus Gasthuisberg | Leuven | Belgium |
| Centre Hospitalier Régional de la Citadelle | Liège | Belgium |
| University of Calgary | Calgary | Canada |
| Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Canada |
| Montreal Heart Institute | Montreal | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Québec | Canada |
| Na Homolce Hospital | Prague | Czechia |
| Odense Universitetshospital | Odense | Denmark |
| 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 | France |
| St. Vinzenz-Hospital Köln | Cologne | Germany |
| Universitätsklinikum Jena - Friedrich Schiller Universität | Jena | Germany |
| Städtisches Klinikum Karlsruhe GmbH | Karlsruhe | Germany |
| Robert Bosch Krankenhaus | Stuttgart | Germany |
| Klinikum Villingen-Schwenningen | Villingen-Schwenningen | Germany |
| Hygeia Hospital | Athens | Greece |
| Barzilai Medical Center Ashkelon | Ashkelon | Israel |
| Azienda Ospedaliera Sepdali Civili di Brescia | Brescia | Italy |
| Maria Cecilia Hospital | Cotignola | Italy |
| Centro Cardiologico Monzino | Milan | Italy |
| Azienda Ospedaliero-Universitaria Pisana | Pisa | Italy |
| Cardiac Vascular Sentral Kuala Lumpur | Kuala Lumpur | Malaysia |
| Institut Jantung Negara | Kuala Lumpur | Malaysia |
| Amsterdam UMC - Locatie AMC | Amsterdam | Netherlands |
| HagaZiekenhuis - Locatie Leyweg | The Hague | Netherlands |
| Akerhus University Hospital | Oslo | Norway |
| 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 |
| Klinicki Centar Srbije | Belgrade | Serbia |
| University Medical Centre Ljubljana | Ljubljana | Slovenia |
| Hospital Universitario da Coruña | A Coruña | Spain |
| 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 | Zurich | 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 |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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