BradycardiaMicra AV PASNCT04253184
Micra AV Transcatheter Pacing System Post-Approval Registry
An observational study of Bradycardia, run by Medtronic at 89 sites in 20 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bradycardia
- What is being tested?
- Micra AV Transcatheter Pacing System
- Type of treatment
- Medical device
- How many people
- 802 participants
- Where
- 89 sitesin 20 countries
- Study dates
- 8 Feb 2020to 14 Jan 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
89 sites in 20 countries.
89 sites in 20 countries
United States46 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Emory University Hospital
Atlanta, Georgia, 30322
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
The John Hopkins Hospital
Baltimore, Maryland, 20817
MedStar Baltimore
Baltimore, Maryland, 21204
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia Medical Center
Charlottesville, Virginia, 22908
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433
Duke University Medical Center
Durham, North Carolina, 27705
Saint Elizabeth Healthcare
Edgewood, Kentucky, 41017
Medicor Associates
Erie, Pennsylvania, 16507
Consultants in Cardiology
Fort Worth, Texas, 76104
Forrest General Hospital
Hattiesburg, Mississippi, 39404
Indiana University Health Methodist Research Institute
Indianapolis, Indiana, 46202
Baptist Health
Jacksonville, Florida, 32207
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Saint Lukes Health System
Kansas City, Missouri, 64111
Northwell Health
Manhasset, New York, 11030
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale New Haven Health System
New Haven, Connecticut, 06520
NYU Langone Medical Center
New York, New York, 10016
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10021
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10022
Monmouth Cardiology
Ocean City, New Jersey, 07712
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120
Lankenau Institute for Medical Research
Philadelphia, Pennsylvania, 19096
University of Pittsburgh Medical Center UPMC Shadyside
Pittsburgh, Pennsylvania, 15213
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
Eisenhower Desert Cardiology Center
Rancho Mirage, California, 92270
Sequoia Hospital
Redwood City, California, 94062
The Valley Hospital
Ridgewood, New Jersey, 07450
Mayo Clinic
Rochester, Minnesota, 55902
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
TidalHealth Peninsula Regional Medical Center
Salisbury, Maryland, 21804
Iowa Heart Center
West Des Moines, Iowa, 50266
Michigan Heart
Ypsilanti, Michigan, 48197
France6 sites
CHRU de Tours - Hopital trousseau
Chambray-lès-Tours
Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied
Clermont-Ferrand
Hôpital Européen Georges-Pompidou
Paris
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac
CHU Toulouse - Hôpital Rangueil
Toulouse
Clinique Pasteur
Toulouse
Germany5 sites
St. Vinzenz-Hospital Köln
Cologne
Universitätsklinikum Jena - Friedrich Schiller Universität
Jena
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe
Robert Bosch Krankenhaus
Stuttgart
Klinikum Villingen-Schwenningen
Villingen-Schwenningen
Canada4 sites
University of Calgary
Calgary
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal
Montreal Heart Institute
Montreal
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec
Italy4 sites
Azienda Ospedaliera Sepdali Civili di Brescia
Brescia
Maria Cecilia Hospital
Cotignola
Centro Cardiologico Monzino
Milan
Azienda Ospedaliero-Universitaria Pisana
Pisa
Belgium3 sites
Universitair Ziekenhuis Brussel
Brussels
UZ Leuven-Campus - Campus Gasthuisberg
Leuven
Centre Hospitalier Régional de la Citadelle
Liège
Spain3 sites
Hospital Universitario da Coruña
A Coruña
Hospital de la Santa Creu I Sant Pau
Barcelona
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela
United Kingdom3 sites
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
Northampton General Hospital NHS Trust
Northampton
Southampton General Hospital
Southampton
Malaysia2 sites
Cardiac Vascular Sentral Kuala Lumpur
Kuala Lumpur
Institut Jantung Negara
Kuala Lumpur
Netherlands2 sites
Amsterdam UMC - Locatie AMC
Amsterdam
HagaZiekenhuis - Locatie Leyweg
The Hague
Switzerland2 sites
Inselspital-Universitatsspital Bern
Bern
UniversitätsSpital Zürich
Zurich
Portugal1 site
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
Carnaxide
Saudi Arabia1 site
King Salman Heart Center - King Fahad Medical City
Riyadh
About this study
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.
Read the 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
- Conditions
- Bradycardia
- Being tested
- Micra AV Transcatheter Pacing System
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micra AV Transcatheter Pacing SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pacemaker syndrome
To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.
Measured: After 3 years of Follow Up
Secondary outcomes (2)
Acute complication rate
To estimate the acute major complication rate related to the Micra AV system and/or procedure.
Measured: 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.
Measured: After 3 years of Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start8 Feb 2020
- Primary completion5 Sep 2025
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 802 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253184
- Sponsor's protocol ID
- Micra AV PAS
- Acronym
- Micra AV PAS
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2020
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micra AV Transcatheter Pacing System Post-Approval Registry
- ClinicalTrials.gov ID
- NCT04253184
- Acronym / sponsor ID
- Micra AV PAS / Micra AV PAS
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micra AV Transcatheter Pacing SystemThe 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. | Device | – |
Primary outcome
Rate of pacemaker syndrome
Time frame: After 3 years of Follow Up
To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.
2 secondary outcomes
Acute complication rate
Time frame: After 30 days of Follow Up
Long-term complication rate
Time frame: After 3 years of Follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Bradycardia
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
RecruitingObservational study
Aveir AR Coverage With Evidence Development (CED) Study
Cardiac Pacemaker, Arrhythmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
89 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Medtronic at 89 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, France, Germany, Canada, Italy and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pacemaker syndrome (time frame: After 3 years of Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.