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
1778
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Spokane, WA
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110
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Akron, OH
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582
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Albany, GA
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1333
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Albuquerque, NM
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798
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Alexandria, LA
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3103
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Anchorage, AK
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436
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Atlanta, GA
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1069
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Austin, TX
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1980
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Bakersfield, CA
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801
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Baton Rouge, LA
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492
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Birmingham, AL
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862
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Bradenton, FL
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446
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Browns Mills, NJ
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590
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Burlington, VT
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Charleston, South Carolina 29412
527
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Charleston, SC
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362
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Chattanooga, TN
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428
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Chesapeake, VA
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1949
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Chula Vista, CA
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98
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Cincinnati, OH
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830
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Clearwater, FL
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127
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Cleveland, OH
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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499
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Columbia, MO
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426
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Columbia, SC
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529
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Columbus, GA
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Columbus, OH
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634
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Coon Rapids, MN
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767
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Covington, LA
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910
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Dallas, TX
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1162
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Denver, CO
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565
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Des Moines, IA
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1969
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Downey, CA
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354
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Durham, NC
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2098
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East Palo Alto, CA
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105
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Edgewood, KY
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Erie, PA
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280
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Evansville, IN
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Fairfax, VA
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857
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Fargo, ND
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437
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Florence, SC
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937
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Fort Worth, TX
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496
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Garden City, NY
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501
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Germantown, TN
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1648
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Gilbert, AZ
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Greensboro, North Carolina 27401
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Greensboro, NC
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442
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Henderson, NY
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991
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Houston, TX
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508
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Huntington, NY
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166
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Indianapolis, IN
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668
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Jacksonville, FL
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506
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Jonesboro, AR
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620
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Kansas City, KS
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618
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Kansas City, MO
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237
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Kingsport, TN
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1926
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La Jolla, CA
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353
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Lancaster, PA
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206
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Lansing, MI
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609
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Lebanon, NH
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154
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Lexington, KY
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4525
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Linz,
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622
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Little Rock, AR
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1975
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Long Beach, CA
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1972
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Los Angeles, CA
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188
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Louisville, KY
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394
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Madison, WI
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425
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Marietta, GA
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504
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Marquette, MI
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832
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Melbourne, FL
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335
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Milwaukee, WI
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624
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Minneapolis, MN
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331
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Nashville, TN
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385
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Newark, DE
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275
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Oak Lawn, IL
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451
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Ocean City, NJ
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2037
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Olympia, WA
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Parlin, NJ
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Plano, TX
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Portland, OR
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490
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Poughkeepsie, NY
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371
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Raleigh, NC
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2058
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Redding, CA
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630
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Robbinsdale, MN
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559
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Rochester, MN
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355
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Rochester, NY
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246
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Saginaw, MI
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627
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Saint Louis Park, MN
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617
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Saint Paul, MN
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Salinas, CA
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411
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Salisbury, MD
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1144
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San Antonio, TX
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1951
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San Diego, CA
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2107
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Santa Rosa, CA
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366
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Sayre, PA
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1653
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Scottsdale, AZ
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326
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Silver Spring, MD
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747
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Sioux Falls, SD
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2012
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Tacoma, WA
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327
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Takoma Park, MD
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831
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Tampa, FL
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974
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The Woodlands, TX
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121
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Toledo, OH
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