Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study

Following product approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network.

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Key information

Conditions

Tachyarrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Sex eligibility

All sexes

Study type

Observational

About this study

Pre-clinical testing and clinical data has demonstrated the safety and effectiveness of magnetic resonance (MR) Conditional Tachyarrhythmia Therapy Systems in the MR environment when used according to labeling requirements. Following approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network. MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Treatment and study plan

Implant of an MR-conditional Tachy device system

Device

Primary outcomes

The proportion of episodes with ≥ 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure.

Time frame: up to 5 years post-approval.

The primary objective will be analyzed and reported when 50 patients with a true VF episode following MR exposure have been identified

Secondary outcomes

The number of patients with 2 or more scans

Time frame: up to 5 years post-approval

The estimate of patients receiving multiple MRI scans will include all patients regardless if the patient has experienced a VF episode.
Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink

Time frame: up to 5 years post-approval

Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink will be summarized for MR CRT-D patients. Summary statistics will be presented separately for pre-MRI and post-MRI PCT measurements

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

Medtronic Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2019
First posted: Jul 29, 2016
Registry last updated: Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed