Clinical trial NCT03402126: Tachy Prediction Download Study
Official title: Tachy Prediction Download Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-01-18
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.)

Primary outcomes:
measure: Number of Participants With Device Detected Ventricular Tachycardia/Ventricular Fibrillation Episodes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Saint Lukes Hospital of Kansas City
state: Missouri
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: Cape Fear Heart Associates
state: North Carolina
city: Columbus
country: United States
facility: Mount Carmel East
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
Study officials:
affiliation: Medtronic
name: Mark Brown
role: STUDY_DIRECTOR
References: