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Micra Transcatheter Pacing System Post-Approval Registry

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ClinicalTrials.gov Identifier: NCT02536118
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief Summary:

Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.

The Micra Registry is conducted within Medtronic's Product Surveillance Registry.


Condition or disease Intervention/treatment
Bradycardia Device: Micra Transcatheter Pacing System

Detailed Description:

The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry*.

Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years.

*Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Years
Official Title: Micra Transcatheter Pacing System Post-Approval Registry
Actual Study Start Date : July 2015
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Group/Cohort Intervention/treatment
Patients implanted with Micra System
Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
Device: Micra Transcatheter Pacing System
The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.
Other Names:
  • Micra
  • Micra TPS




Primary Outcome Measures :
  1. Acute complication rate [ Time Frame: 30-days ]
    To estimate acute complication rate related to the Micra system and/or implant procedure.

  2. Long-term complication free survival [ Time Frame: 9 years ]
    To estimate the chronic complication free survival rate of the Micra system.


Secondary Outcome Measures :
  1. Pacing impedance (ohms) and pacing threshold (volts) [ Time Frame: Up to 9 years ]
    Summary statistics of electrical performance 5-years post-implant measurements will be reported.

  2. Complications stratified by implant type [ Time Frame: Up to 9 years ]
    A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness.

  3. Estimate Micra System revision rate [ Time Frame: Up to 9 years ]
    Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.

  4. Estimate System Longevity [ Time Frame: Up to 9 years ]
    Summary statistics regarding battery length will be reported.

  5. Confirm the rate response operation of the Micra system [ Time Frame: Approximately 2 years ]
    Analysis of treadmill testing data from patients implanted with Micra for at least 3 months. Rate response data collected in the registry will be combined with data from the FDA Investigational Device Exemption study (NCT 02004873).


Other Outcome Measures:
  1. Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment [ Time Frame: Up to 9 years ]
    Micra System performance will be described following use in an MR environment. A listing of MRI related events, pacing impedance (ohms) and pacing threshold (volts) over time following MR exposure may be reported.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients intended to be implanted with a Micra 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 system will be followed for a minimum of 9 years, unless a patient is exited from the registry due to an unavoidable reason such as death, physician discretion, or patient withdrawal of consent, or unless the patient is participating in an acute performance sub-study of the Micra Registry. If a Micra system is not successfully implanted, patients will be exited from the registry unless a Micra 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.

Criteria

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 Transcatheter Pacing System and must be enrolled prior to the TPS 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536118


Contacts
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Contact: Micra Registry Manager rs.productsurveillanceregistry@medtronic.com

  Hide Study Locations
Locations
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United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, California
Recruiting
Los Angeles, California, United States
Recruiting
Redwood City, California, United States
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Recruiting
Clearwater, Florida, United States
Recruiting
Jacksonville, Florida, United States
Recruiting
Safety Harbor, Florida, United States
United States, Georgia
Recruiting
Atlanta, Georgia, United States
United States, Indiana
Recruiting
Indianapolis, Indiana, United States
United States, Iowa
Recruiting
West Des Moines, Iowa, United States
United States, Kansas
Recruiting
Kansas City, Kansas, United States
United States, Kentucky
Recruiting
Edgewood, Kentucky, United States
Recruiting
Louisville, Kentucky, United States
United States, Maryland
Recruiting
Salisbury, Maryland, United States
Recruiting
Silver Spring, Maryland, United States
Recruiting
Takoma Park, Maryland, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, Michigan
Active, not recruiting
Ann Arbor, Michigan, United States
Recruiting
Lansing, Michigan, United States
Recruiting
Ypsilanti, Michigan, United States
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States
Recruiting
Rochester, Minnesota, United States
Recruiting
Saint Cloud, Minnesota, United States
United States, Missouri
Recruiting
Columbia, Missouri, United States
Recruiting
Kansas City, Missouri, United States
United States, New Jersey
Recruiting
Morristown, New Jersey, United States
Recruiting
Ridgewood, New Jersey, United States
United States, New York
Recruiting
Huntington, New York, United States
Recruiting
New York, New York, United States
Recruiting
Poughkeepsie, New York, United States
United States, North Carolina
Recruiting
Durham, North Carolina, United States
Recruiting
Raleigh, North Carolina, United States
United States, Ohio
Recruiting
Akron, Ohio, United States
Recruiting
Cincinnati, Ohio, United States
Recruiting
Cleveland, Ohio, United States
Recruiting
Columbus, Ohio, United States
Recruiting
Toledo, Ohio, United States
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Allentown, Pennsylvania, United States
Recruiting
Lancaster, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
Recruiting
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Recruiting
Germantown, Tennessee, United States
Recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
Austin, Texas, United States
Recruiting
Dallas, Texas, United States
Recruiting
Fort Worth, Texas, United States
Recruiting
Houston, Texas, United States
Recruiting
Plano, Texas, United States
United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States
Belgium
Active, not recruiting
Brussel, Belgium
Active, not recruiting
Edegem, Belgium
Active, not recruiting
Leuven, Belgium
Canada, Ontario
Recruiting
Kingston, Ontario, Canada
Canada
Recruiting
Montréal, Canada
Czechia
Not yet recruiting
Praha, Czechia
Denmark
Active, not recruiting
Arhus, Denmark
Active, not recruiting
Hillerød, Denmark
Active, not recruiting
Kobenhavn, Denmark
Active, not recruiting
Odense, Denmark
France
Active, not recruiting
Annecy, France
Active, not recruiting
Bayonne, France
Active, not recruiting
Bordeaux, France
Active, not recruiting
Brest, France
Active, not recruiting
Chambray les tours, France
Active, not recruiting
Clermont Ferrand Cedex, France
Active, not recruiting
Grenoble, France
Active, not recruiting
Lille, France
Active, not recruiting
Marseille, France
Active, not recruiting
Montpellier, France
Active, not recruiting
Nancy, France
Active, not recruiting
Nantes, France
Active, not recruiting
Neuilly Sur Seine, France
Active, not recruiting
Rennes Cedex 9, France
Active, not recruiting
Rouen, France
Active, not recruiting
Saint Etienne, France
Active, not recruiting
Saint-Denis, France
Active, not recruiting
Strasbourg, France
Active, not recruiting
Toulouse, France
Active, not recruiting
Villeurbanne, France
Germany
Active, not recruiting
Aachen, Germany
Active, not recruiting
Berlin, Germany
Active, not recruiting
Dresden, Germany
Active, not recruiting
Dusseldorf, Germany
Active, not recruiting
Frankfurt, Germany
Active, not recruiting
Hamburg, Germany
Active, not recruiting
Hannover, Germany
Active, not recruiting
Heidelberg, Germany
Active, not recruiting
Jena, Germany
Active, not recruiting
Köln, Germany
Active, not recruiting
Mainz, Germany
Active, not recruiting
Munster, Germany
Active, not recruiting
Tübingen, Germany
Active, not recruiting
Ulm, Germany
Greece
Active, not recruiting
Athens, Greece
Active, not recruiting
Marousi, Greece
Hungary
Not yet recruiting
Budapest, Hungary
Iceland
Active, not recruiting
Rykjavik, Iceland
Israel
Active, not recruiting
Ashqelon, Israel
Active, not recruiting
Jerusalem, Israel
Active, not recruiting
Ramat-Gan, Israel
Italy
Active, not recruiting
Bari, Italy
Active, not recruiting
Bologna, Italy
Active, not recruiting
Brescia, Italy
Active, not recruiting
Cotignola, Italy
Active, not recruiting
Milano, Italy
Active, not recruiting
Pisa, Italy
Active, not recruiting
Roma, Italy
Japan
Recruiting
Mitaka-shi, Tokyo, Japan
Recruiting
Shinagawa, Tokyo, Japan
Recruiting
Suita, Japan
Recruiting
Yokohama, Japan
Kuwait
Active, not recruiting
Hadiya, Kuwait
Netherlands
Active, not recruiting
Amsterdam, Netherlands
Active, not recruiting
Breda, Netherlands
Active, not recruiting
Den Haag, Netherlands
Active, not recruiting
Eindhoven, Netherlands
Active, not recruiting
Enschede, Netherlands
Active, not recruiting
Groningen, Netherlands
Active, not recruiting
Leiden, Netherlands
Active, not recruiting
Maastricht, Netherlands
Active, not recruiting
Nieuwegein, Netherlands
Active, not recruiting
Rotterdam, Netherlands
New Zealand
Active, not recruiting
Christchurch, New Zealand
Norway
Active, not recruiting
Bergen, Norway
Active, not recruiting
Trondheim, Norway
Poland
Active, not recruiting
Poznan, Poland
Active, not recruiting
Zabrze, Poland
Portugal
Active, not recruiting
Lisboa, Portugal
Saudi Arabia
Active, not recruiting
Jeddah, Saudi Arabia
Active, not recruiting
Riyadh, Saudi Arabia
Spain
Active, not recruiting
Barcelona, Spain
Active, not recruiting
Coruña, Spain
Active, not recruiting
Santiago de Compostela, Spain
Active, not recruiting
Toledo, Spain
Active, not recruiting
Vitoria-Gasteiz, Spain
Sweden
Active, not recruiting
Uppsala, Sweden
Switzerland
Active, not recruiting
Basel, Switzerland
Active, not recruiting
Bern, Switzerland
Active, not recruiting
Fribourg, Switzerland
Active, not recruiting
Geneve, Switzerland
Active, not recruiting
Lausanne, Switzerland
Active, not recruiting
Lugano, Switzerland
Active, not recruiting
Zurich, Switzerland
United Kingdom
Active, not recruiting
Birmingham, United Kingdom
Active, not recruiting
Bristol, United Kingdom
Active, not recruiting
Leeds, United Kingdom
Active, not recruiting
Leicester, United Kingdom
Active, not recruiting
Liverpool, United Kingdom
Active, not recruiting
London, United Kingdom
Active, not recruiting
Manchester, United Kingdom
Active, not recruiting
Middlesbrough, United Kingdom
Active, not recruiting
Nottingham, United Kingdom
Active, not recruiting
Southhamptom, United Kingdom
Sponsors and Collaborators
Medtronic
Investigators
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Study Director: Micra Registry Manager Medtronic

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT02536118     History of Changes
Other Study ID Numbers: Micra Registry
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes