Tachy Prediction Download Study

Ventricular Tachycardia Clinical Trial

— TPD  

Official title:

Tachy Prediction Download Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402126
• Other study ID #: TPD Study
• Status: Completed
• 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
• 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.)

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

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