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

June 4, 2019 updated by: Medtronic

Medtronic 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

10979

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 5 years post-approval.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 5 years post-approval
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
up to 5 years post-approval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Investigators

  • Study Chair: Product Surveillance Registry Medtronic Product Surveillance Registry, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR Tachy PAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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