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
340
mi
from
West Des Moines, IA
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898
mi
from
Akron, OH
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1209
mi
from
Allentown, PA
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808
mi
from
Ann Arbor, MI
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801
mi
from
Atlanta, GA
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522
mi
from
Austin, TX
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683
mi
from
Birmingham, AL
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1444
mi
from
Boston, MA
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?
mi
from
Brussel,
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726
mi
from
Cincinnati, OH
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1102
mi
from
Clearwater, FL
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895
mi
from
Cleveland, OH
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310
mi
from
Columbia, MO
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810
mi
from
Columbus, OH
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349
mi
from
Dallas, TX
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1051
mi
from
Durham, NC
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721
mi
from
Edgewood, KY
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346
mi
from
Fort Worth, TX
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481
mi
from
Germantown, TN
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569
mi
from
Houston, TX
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1317
mi
from
Huntington, NY
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643
mi
from
Indianapolis, IN
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1053
mi
from
Jacksonville, FL
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196
mi
from
Kansas City, KS
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198
mi
from
Kansas City, MO
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1163
mi
from
Lancaster, PA
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779
mi
from
Lansing, MI
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1168
mi
from
Los Angeles, CA
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657
mi
from
Louisville, KY
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630
mi
from
Milwaukee, WI
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552
mi
from
Minneapolis, MN
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1262
mi
from
Morristown, NJ
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618
mi
from
Nashville, TN
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1344
mi
from
New Haven, CT
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1290
mi
from
New York, NY
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158
mi
from
Oklahoma City, OK
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1225
mi
from
Philadelphia, PA
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971
mi
from
Pittsburgh, PA
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332
mi
from
Plano, TX
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1383
mi
from
Portland, OR
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1294
mi
from
Poughkeepsie, NY
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1064
mi
from
Raleigh, NC
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1334
mi
from
Redwood City, CA
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1281
mi
from
Ridgewood, NJ
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515
mi
from
Rochester, MN
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1104
mi
from
Safety Harbor, FL
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571
mi
from
Saint Cloud, MN
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1206
mi
from
Salisbury, MD
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1127
mi
from
Silver Spring, MD
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1128
mi
from
Takoma Park, MD
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805
mi
from
Toledo, OH
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1127
mi
from
Washington,
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810
mi
from
Ypsilanti, MI
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