MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/28/2018
Start Date:July 2008
End Date:December 2015

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

Medtronic Adapta/Versa/Sensia Long Term Reliability Study

The primary purpose of this study is to assess the long term reliability of the Medtronic
Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of
approval of nEw3 devices. Patients will be followed for 5 years after implant. This study
utilizes data collected from the System Longevity Study (SLS).

The rate of device malfunctions will be determined and a comparison to historical controls
will be done.

Inclusion Criteria:

- Subjects or appropriate legal guardians provide written informed consent and/or
authorization for access to and use of health information, as required by an
institution's IRB/MEC/REB.

AND one of the following must also apply:

- Subjects indicated for implant or within six months post-implant of a Medtronic
market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The
Medtronic lead must be used for pacing, sensing or defibrillation application.

- Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy
product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is
market-released 3) complete implant and follow-up data, including product-related
adverse events are available and 4) subject of appropriate legal guardian authorizes
release of subject study data to SLS

- Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic
CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to
retrospectively collect data for post approval requirements.

Exclusion Criteria:

- Subjects who are, or will be inaccessible for follow-up at a SLS center

- Subjects with exclusion criteria required by local law (EMEA only)

- Subjects receiving an implant of a Medtronic device at a non-participating center and
the implant data and current status cannot be confirmed within 30 days after implant

- Subjects implanted with a Medtronic device whose predetermined enrollment limit for
that specific product has been exceeded
We found this trial at
111
sites
810
mi
from
Columbus, OH
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898
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from
Akron, OH
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884
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from
Albany, GA
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523
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from
Albuquerque, NM
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540
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from
Alexandria, LA
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2734
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from
Anchorage, AK
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801
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from
Atlanta, GA
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522
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from
Austin, TX
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1184
mi
from
Bakersfield, CA
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637
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from
Baton Rouge, LA
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683
mi
from
Birmingham, AL
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1132
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from
Bradenton, FL
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1255
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from
Browns Mills, NJ
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1356
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from
Burlington, VT
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Charleston, South Carolina 29412
1064
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from
Charleston, SC
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719
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Chattanooga, TN
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1185
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Chesapeake, VA
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1140
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from
Chula Vista, CA
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726
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from
Cincinnati, OH
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1102
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Clearwater, FL
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895
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from
Cleveland, OH
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Colorado Springs, Colorado 80910
383
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from
Colorado Springs, CO
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310
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from
Columbia, MO
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972
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from
Columbia, SC
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811
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from
Columbus, GA
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563
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from
Coon Rapids, MN
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668
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from
Covington, LA
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349
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from
Dallas, TX
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409
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from
Denver, CO
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346
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from
Des Moines, IA
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1164
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from
Downey, CA
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1051
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from
Durham, NC
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1327
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from
East Palo Alto, CA
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721
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from
Edgewood, KY
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983
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from
Erie, PA
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559
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from
Evansville, IN
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1114
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from
Fairfax, VA
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635
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from
Fargo, ND
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1037
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from
Florence, SC
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346
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from
Fort Worth, TX
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1306
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from
Garden City, NY
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481
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from
Germantown, TN
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838
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from
Gilbert, AZ
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Greensboro, North Carolina 27401
1002
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from
Greensboro, NC
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1203
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from
Henderson, NY
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569
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from
Houston, TX
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1317
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from
Huntington, NY
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643
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from
Indianapolis, IN
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1053
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from
Jacksonville, FL
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415
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from
Jonesboro, AR
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196
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from
Kansas City, KS
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198
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from
Kansas City, MO
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843
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from
Kingsport, TN
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1118
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from
La Jolla, CA
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1163
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from
Lancaster, PA
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779
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from
Lansing, MI
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1393
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from
Lebanon, NH
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725
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from
Lexington, KY
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5180
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from
Linz,
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372
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from
Little Rock, AR
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1171
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from
Long Beach, CA
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1168
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from
Los Angeles, CA
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657
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from
Louisville, KY
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574
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from
Madison, WI
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788
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from
Marietta, GA
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807
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from
Marquette, MI
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1198
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from
Melbourne, FL
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630
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from
Milwaukee, WI
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552
mi
from
Minneapolis, MN
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618
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from
Nashville, TN
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1193
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from
Newark, DE
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600
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from
Oak Lawn, IL
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1257
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from
Ocean City, NJ
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1427
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from
Olympia, WA
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1269
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from
Parlin, NJ
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332
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from
Plano, TX
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1383
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from
Portland, OR
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1294
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from
Poughkeepsie, NY
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1064
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from
Raleigh, NC
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1326
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from
Redding, CA
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553
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from
Robbinsdale, MN
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515
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from
Rochester, MN
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1122
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from
Rochester, NY
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826
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from
Saginaw, MI
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548
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from
Saint Louis Park, MN
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553
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from
Saint Paul, MN
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1309
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from
Salinas, CA
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1206
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from
Salisbury, MD
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583
mi
from
San Antonio, TX
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1143
mi
from
San Diego, CA
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1348
mi
from
Santa Rosa, CA
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1163
mi
from
Sayre, PA
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843
mi
from
Scottsdale, AZ
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1127
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from
Silver Spring, MD
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404
mi
from
Sioux Falls, SD
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1201
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from
Spokane, WA
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1407
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from
Tacoma, WA
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1128
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from
Takoma Park, MD
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1117
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from
Tampa, FL
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541
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from
The Woodlands, TX
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805
mi
from
Toledo, OH
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