Micra Transcatheter Pacing System Post-Approval Registry



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:1/20/2019
Start Date:July 2015
End Date:August 2026
Contact:Micra Registry Manager
Email:rs.productsurveillanceregistry@medtronic.com

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
53
sites
1966
mi
from 98109
Edgewood, KY
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2041
mi
from 98109
Akron, OH
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2337
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from 98109
Allentown, PA
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1903
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from 98109
Ann Arbor, MI
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2178
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from 98109
Atlanta, GA
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1775
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from 98109
Austin, TX
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2079
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from 98109
Birmingham, AL
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2485
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from 98109
Boston, MA
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?
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from 98109
Brussel,
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1967
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from 98109
Cincinnati, OH
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2512
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from 98109
Clearwater, FL
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2020
mi
from 98109
Cleveland, OH
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1614
mi
from 98109
Columbia, MO
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2004
mi
from 98109
Columbus, OH
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1682
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from 98109
Dallas, TX
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2341
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from 98109
Durham, NC
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1660
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from 98109
Fort Worth, TX
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1877
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from 98109
Germantown, TN
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1890
mi
from 98109
Houston, TX
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2423
mi
from 98109
Huntington, NY
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1867
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from 98109
Indianapolis, IN
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2449
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from 98109
Jacksonville, FL
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1500
mi
from 98109
Kansas City, KS
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1503
mi
from 98109
Kansas City, MO
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2315
mi
from 98109
Lancaster, PA
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1853
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from 98109
Lansing, MI
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962
mi
from 98109
Los Angeles, CA
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1939
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from 98109
Louisville, KY
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1681
mi
from 98109
Milwaukee, WI
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1393
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from 98109
Minneapolis, MN
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2377
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from 98109
Morristown, NJ
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1970
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from 98109
Nashville, TN
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2432
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from 98109
New Haven, CT
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2400
mi
from 98109
New York, NY
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1523
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from 98109
Oklahoma City, OK
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2373
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from 98109
Philadelphia, PA
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2132
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from 98109
Pittsburgh, PA
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1673
mi
from 98109
Plano, TX
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147
mi
from 98109
Portland, OR
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2374
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from 98109
Poughkeepsie, NY
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2358
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from 98109
Raleigh, NC
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704
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from 98109
Redwood City, CA
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2388
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from 98109
Ridgewood, NJ
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1450
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from 98109
Rochester, MN
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2514
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from 98109
Safety Harbor, FL
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1337
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from 98109
Saint Cloud, MN
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2406
mi
from 98109
Salisbury, MD
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2319
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from 98109
Silver Spring, MD
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2320
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from 98109
Takoma Park, MD
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1929
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from 98109
Toledo, OH
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2322
mi
from 98109
Washington,
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1457
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from 98109
West Des Moines, IA
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1909
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from 98109
Ypsilanti, MI
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