NCT02849769

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,979

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Status
completed

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

Study Start

First participant enrolled

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

3.3 years

First QC Date

July 27, 2016

Last Update Submit

June 4, 2019

Conditions

Tachyarrhythmia

Outcome Measures

Primary Outcomes (1)

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

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

    up to 5 years post-approval.

Secondary Outcomes (2)

  • The number of patients with 2 or more scans

    up to 5 years post-approval

  • Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink

    up to 5 years post-approval

Study Arms (1)

Patients implanted with an MR-conditional Tachy device system

Patients implanted with an MR-conditional Tachy device system in the routine care

Device: Implant of an MR-conditional Tachy device system

Interventions

Implant of an MR-conditional Tachy device systemDEVICE
Patients implanted with an MR-conditional Tachy device system

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Product Surveillance Registry Medtronic Product Surveillance Registry

    Medtronic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

July 29, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2018

Study Completion

May 1, 2019

Last Updated

June 5, 2019

Record last verified: 2019-06