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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03402126
Other study ID # TPD Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2018
Est. completion date February 26, 2020

Study information

Verified date November 2021
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date February 26, 2020
Est. primary completion date February 26, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design


Intervention

Other:
TPD RAMWare
TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use

Locations

Country Name City State
Hong Kong Princess Margaret Hospital Hong Kong
United States Texas Cardiac Arrhythmia Research Foundation Austin Texas
United States Carolinas Medical Center Charlotte North Carolina
United States Mount Carmel East Columbus Ohio
United States Iowa Heart Center Des Moines Iowa
United States The Stern Cardiovascular Foundation Germantown Tennessee
United States Saint Lukes Hospital of Kansas City Kansas City Missouri
United States Bryan Heart Lincoln Nebraska
United States Cedars-Sinai Medical Center Los Angeles California
United States Morristown Memorial Hospital Morristown New Jersey
United States Centennial Heart Cardiovascular Consultants Nashville Tennessee
United States Oklahoma Heart Hospital Research Foundation Oklahoma City Oklahoma
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 Cape Fear Heart Associates Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes This was a data collection study collecting data when implanted device detected Ventricular Tachycardia/Ventricular Fibrillation. 1 year
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