Micra AV Transcatheter Pacing System Post-Approval Registry

NCT04253184 | Completed

• 1 other identifier: Micra AV PAS
• Study Type: observational
• Target: 802
• Locations: 20 countries
• Sites: 89

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.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Acute complication rate

  After 30 days of Follow Up

• Long-term complication rate

  After 3 years of Follow up

Other Outcomes (5)

• AV Synchrony Loss

  After 3 years of Follow up

• System and Procedure Related Adverse Events

  After 3 years of Follow up

• Implant Characteristics

  Up to 3 years of Follow Up

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient who is, or is expected to be inaccessible for follow-up
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Sponsors & Collaborators

• Medtronic: lead

Study Sites (89)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Eisenhower Desert Cardiology Center

Rancho Mirage, California, 92270, United States

Location

Sequoia Hospital

Redwood City, California, 94062, United States

Location

Yale New Haven Health System

New Haven, Connecticut, 06520, United States

Location

Baptist Health

Jacksonville, Florida, 32207, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Indiana University Health Methodist Research Institute

Indianapolis, Indiana, 46202, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

Location

Saint Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

The John Hopkins Hospital

Baltimore, Maryland, 20817, United States

Location

MedStar Baltimore

Baltimore, Maryland, 21204, United States

Location

TidalHealth Peninsula Regional Medical Center

Salisbury, Maryland, 21804, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Metropolitan Cardiology Consultants

Coon Rapids, Minnesota, 55433, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

United Heart and Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

Forrest General Hospital

Hattiesburg, Mississippi, 39404, United States

Location

Saint Lukes Health System

Kansas City, Missouri, 64111, United States

Location

Monmouth Cardiology

Ocean City, New Jersey, 07712, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10021, United States

Location

New York-Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10022, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, 73120, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Medicor Associates

Erie, Pennsylvania, 16507, United States

Location

Lankenau Institute for Medical Research

Philadelphia, Pennsylvania, 19096, United States

Location

University of Pittsburgh Medical Center UPMC Shadyside

Pittsburgh, Pennsylvania, 15213, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Consultants in Cardiology

Fort Worth, Texas, 76104, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 53215, United States

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

UZ Leuven-Campus - Campus Gasthuisberg

Leuven, Belgium

Location

Centre Hospitalier Régional de la Citadelle

Liège, Belgium

Location

University of Calgary

Calgary, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Canada

Location

Montreal Heart Institute

Montreal, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Canada

Location

Na Homolce Hospital

Prague, Czechia

Location

Odense Universitetshospital

Odense, Denmark

Location

CHRU de Tours - Hopital trousseau

Chambray-lès-Tours, France

Location

Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied

Clermont-Ferrand, France

Location

Hôpital Européen Georges-Pompidou

Paris, France

Location

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, France

Location

CHU Toulouse - Hôpital Rangueil

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

St. Vinzenz-Hospital Köln

Cologne, Germany

Location

Universitätsklinikum Jena - Friedrich Schiller Universität

Jena, Germany

Location

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Germany

Location

Robert Bosch Krankenhaus

Stuttgart, Germany

Location

Klinikum Villingen-Schwenningen

Villingen-Schwenningen, Germany

Location

Hygeia Hospital

Athens, Greece

Location

Barzilai Medical Center Ashkelon

Ashkelon, Israel

Location

Azienda Ospedaliera Sepdali Civili di Brescia

Brescia, Italy

Location

Maria Cecilia Hospital

Cotignola, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Location

Cardiac Vascular Sentral Kuala Lumpur

Kuala Lumpur, Malaysia

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

Amsterdam UMC - Locatie AMC

Amsterdam, Netherlands

Location

HagaZiekenhuis - Locatie Leyweg

The Hague, Netherlands

Location

Akerhus University Hospital

Oslo, Norway

Location

Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz

Carnaxide, Portugal

Location

King Salman Heart Center - King Fahad Medical City

Riyadh, Saudi Arabia

Location

Klinicki Centar Srbije

Belgrade, Serbia

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Hospital Universitario da Coruña

A Coruña, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Inselspital-Universitatsspital Bern

Bern, Switzerland

Location

UniversitätsSpital Zürich

Zurich, Switzerland

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: February 8, 2020
• Primary Completion: September 5, 2025
• Study Completion: January 14, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); GR (1); BE (3); IL (1); ES (3); FR (6); GB (3); SA (1); NO (1); US (46); DE (5); MY (2); SE (1); CH (2); DK (1); CA (4); SL (1); PT (1); IT (4); NL (2)