Tachy Prediction Download Study (TPD)

Medtronic

Status

Completed

Conditions

Ventricular Tachycardia

Treatments

Other: TPD RAMWare

Study type

Observational

Funder types

Industry

Identifiers

NCT03402126

TPD Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

138 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)