NCT03402126

Tachy Prediction Download Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
OTHER	TPD RAMWare	TPD RAMWare injected into enrolled subject's Implantable cardioverter-defibrillator (ICD) device for use

Timeline

• Start date: 2018-01-12
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2018-01-18
• Last updated: 2021-11-16
• Results posted: 2021-11-16

Locations

16 sites across 2 countries: United States, Hong Kong

Regulatory

• FDA-regulated device study