Status:
COMPLETED
Tachy Prediction Download Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
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...
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....
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
January 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT03402126
Start Date
January 12 2018
End Date
February 26 2020
Last Update
November 16 2021
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Iowa Heart Center
Des Moines, Iowa, United States, 50266
3
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
4
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States, 56303