Tachy Prediction Download Study (TPD)

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Other: TPD RAMWare

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.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Iowa
    • Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital - Royal Oak
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart & Vascular Center
    • Saint Paul, Minnesota, United States, 55102
      • United Heart and Vascular Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Lukes Hospital of Kansas City
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Memorial Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Wilmington, North Carolina, United States, 28401
      • Cape Fear Heart Associates
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Mount Carmel East
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital Research Foundation
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart Cardiovascular Consultants
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TPD RAMWare Download; Subjects who qualify and consent to participate in the TPD study will have TPD RAMWare injected into their device to collect data.	Other: TPD RAMWare; TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Director: Mark Brown, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: TPD Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No