Tachy Prediction Download Study
TPD
1 other identifier
observational
138
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2017
CompletedStudy Start
First participant enrolled
January 12, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2020
CompletedResults Posted
Study results publicly available
November 16, 2021
CompletedNovember 16, 2021
November 1, 2021
2.1 years
December 18, 2017
August 26, 2020
November 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use
Eligibility Criteria
The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Iowa Heart Center
Des Moines, Iowa, 50266, United States
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102, United States
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07960, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Cape Fear Heart Associates
Wilmington, North Carolina, 28401, United States
Mount Carmel East
Columbus, Ohio, 43213, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, 37203, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Princess Margaret Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joy Aso, Clinical Research Specialist
- Organization
- Medtronic Inc
Study Officials
- STUDY DIRECTOR
Mark Brown
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2017
First Posted
January 18, 2018
Study Start
January 12, 2018
Primary Completion
February 26, 2020
Study Completion
February 26, 2020
Last Updated
November 16, 2021
Results First Posted
November 16, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share