Tachy Prediction Download Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:January 12, 2018
End Date:December 31, 2020
Contact:Michael Bennett
Email:michael.s.bennett@medtronic.com
Phone:(763)213-7342

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

The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an
implantable cardiac defibrillator (ICD) device that will be used to identify markers for
imminent onset of ventricular arrhythmias.

The TPD Study is a prospective, non-randomized, non-interventional, multi-site data
collection clinical study to collect ICD longitudinal data that may be used to develop a
VT/VF prediction algorithm. The study subjects will include patients currently implanted, or
who will be implanted with a market-approved Medtronic Evera MRI® ICD.

Inclusion Criteria:

- Subject is implanted or will be implanted, with an Evera MRI device with properly
functioning Medtronic tachycardia lead placed in the right ventricle (with or without
atrial lead) with remaining device longevity of 4 years or more for:

- Secondary Prevention or,

- Primary Prevention and has had a device treated VT/VF or a device recorded
episode of sustained VT/VF

- Subject is ≥ 18 years old

- Subject has previously documented history of VT/VF

- Subject must be willing and able to use Medtronic CareLink network monitoring system

- Subject provides signed and dated authorization and/or consent per institution and
local requirements

- Subject is willing and able to comply with the protocol

Exclusion Criteria:

- Subject who received device for Primary Prevention indication and who has not had
either a device treated VT/VF episode or a device recorded episode of sustained VT/VF

- Subject is enrolled in a concurrent study that may confound the results of this study,
without documented pre-approval from a Medtronic study manager

- Subject has chronic AF

- Subject has inherited disorders of ion transport mechanisms that predispose the
subject to sudden death ("Channelopathies"): Long QT and Brugada Syndromes

- Subject with multiple implanted active devices that may cause an interruption of a
transmission of device data to CareLink

- Subject has active electronic medical device other than an ICD

- Subject requires more than 25% atrial or ventricular pacing

- Subject has medical conditions that would limit study participation (per investigator
judgment)

- Subject has projected life expectancy of less than 1 year

- Subject is pregnant or plans to be pregnant over the next year (females of
child-bearing potential must have a negative pregnancy test within one week of
enrollment and must practice a reliable form of birth control while enrolled in the
study)

- Subject meets exclusion criteria required by local law (e.g. age, breastfeeding, etc.)
We found this trial at
16
sites
2-10 Princess Margaret Hospital Road
Hong Kong,
Phone: +852 29903322
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Hong Kong,
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Phone: 704-355-4794
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Charlotte, NC
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-248-6679
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Austin, Texas 78758
Phone: 512-807-3150
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Austin, TX
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Columbus, Ohio 43213
Phone: 614-224-2281
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Columbus, OH
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Des Moines, Iowa 50314
Phone: 515-633-3600
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Des Moines, IA
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Germantown, Tennessee 38138
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Germantown, TN
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Phone: 816-931-1883
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Kansas City, MO
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Lincoln, Nebraska 68506
Phone: 402-483-3291
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Lincoln, NE
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Phone: 973-971-4261
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Morristown, NJ
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Nashville, Tennessee 37203
Phone: 615-515-1900
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Nashville, TN
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Oklahoma City, Oklahoma 73120
Phone: 405-608-3800
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Oklahoma City, OK
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Royal Oak, Michigan 48314
Phone: 248-267-5050
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Royal Oak, MI
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
Phone: 320-656-7020
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Saint Cloud, MN
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Saint Paul, Minnesota 55102
Phone: 651-290-0133
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Saint Paul, MN
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Wilmington, North Carolina 28401
Phone: 910-662-9500
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Wilmington, NC
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