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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02849769
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic

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.

Condition or disease Intervention/treatment
Tachyarrhythmia Device: Implant of an MR-conditional Tachy device system

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.

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Study Type : Observational
Actual Enrollment : 10979 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : May 2019

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849769


Sponsors and Collaborators
Medtronic
Investigators
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Study Chair: Product Surveillance Registry Medtronic Product Surveillance Registry Medtronic

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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT02849769    
Other Study ID Numbers: MR Tachy PAS
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes