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Tachy Prediction Download Study (TPD)

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ClinicalTrials.gov Identifier: NCT03402126
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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.

Condition or disease Intervention/treatment
Ventricular Tachycardia Other: TPD RAMWare

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tachy Prediction Download Study
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TPD RAMWare Download
Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.
Other: TPD RAMWare
TPD RAMWare injected into enrolled subject's device.




Primary Outcome Measures :
  1. Data Collection to Identify Markers for Imminent Onset of Ventricular Arrhythmias [ Time Frame: 1 year ]
    Individual Patient Data will include electrical markers of heart activity and other physiologic data prior to these ventricular arrhythmias, as well as matching control data, collected to aid prediction of the imminent onset of ventricular arrhythmias.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402126


Contacts
Contact: Michael Bennett (763)213-7342 michael.s.bennett@medtronic.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Michael Shehata, MD    310-248-6679    michael.shehata@cshs.org   
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50266
Contact: Jason Meyers, MD    515-633-3600    jasonmeyers@iowaheart.com   
United States, Michigan
Beaumont Hospital - Royal Oak Not yet recruiting
Royal Oak, Michigan, United States, 48073
Contact: Brian Williamson, MD    248-267-5050    bwilliamson@beaumont.edu   
United States, Minnesota
CentraCare Heart & Vascular Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: John Schoenhard, MD    320-656-7020    john.schoenhard@gmail.com   
United Heart and Vascular Clinic Not yet recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Michael Peterson, MD    651-290-0133    michael.peterson@allina.com   
United States, Missouri
Saint Lukes Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Michael Giocondo, MD    816-931-1883    mgiocondo@saint-lukes.org   
United States, Nebraska
Bryan Heart Recruiting
Lincoln, Nebraska, United States, 68506
Contact: W. Michael Kutayli    402-483-3291    drkutayli@bryanheart.com   
United States, New Jersey
Morristown Memorial Hospital Not yet recruiting
Morristown, New Jersey, United States, 07960
Contact: Jonathan Sussman, MD    973-971-4261    jonathan.sussman@atlantichealth.org   
United States, North Carolina
Carolinas Medical Center Not yet recruiting
Charlotte, North Carolina, United States, 28203
Contact: Rohit Mehta, MD    704-355-4794    rohit.mehta@carolinashealthcare.org   
Cape Fear Heart Associates Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Meena Rao, MD    910-662-9500    meena.rao@nhrmc.org   
United States, Ohio
Mount Carmel East Not yet recruiting
Columbus, Ohio, United States, 43213
Contact: Laura Gravlin, MD    614-224-2281    Laura.gravelin@mchs.com   
United States, Oklahoma
Oklahoma Heart Hospital Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Jack Collier, MD    405-608-3800    jcollier@okheart.com   
United States, Tennessee
The Stern Cardiovascular Foundation Recruiting
Germantown, Tennessee, United States, 38138
Contact: Christopher Ingelmo, MD       cingelmo@sterncardio.com   
Centennial Heart Cardiovascular Consultants Recruiting
Nashville, Tennessee, United States, 37203
Contact: Peter Borek, MD    615-515-1900    przemyslaw.borek@hcahealthcare.com   
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Robert Canby, MD    512-807-3150    tcarfrcc@gmail.com   
Hong Kong
Princess Margaret Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ngai-Yin Chan, MD    +852 29903322    ngaiyinchan@yahoo.com.hk   
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Study Director: Mark Brown Medtronic

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03402126     History of Changes
Other Study ID Numbers: TPD Study
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes