Tachy Prediction Download Study

Completed

Conditions studied: Ventricular Tachycardia

In brief

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.

Key facts

Study ID

NCT03402126

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

138

Starts

2018-01-12

Expected to finish

2020-02-26

Last updated by the study team

2021-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Beaumont Hospital - Royal Oak — Royal Oak, Michigan, United States
• CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States
• United Heart and Vascular Clinic — Saint Paul, Minnesota, United States
• Saint Lukes Hospital of Kansas City — Kansas City, Missouri, United States
• Bryan Heart — Lincoln, Nebraska, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Cape Fear Heart Associates — Wilmington, North Carolina, United States
• Mount Carmel East — Columbus, Ohio, United States
• Oklahoma Heart Hospital Research Foundation — Oklahoma City, Oklahoma, United States
• The Stern Cardiovascular Foundation — Germantown, Tennessee, United States
• Centennial Heart Cardiovascular Consultants — Nashville, Tennessee, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• Princess Margaret Hospital — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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