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NCT02652481 · ClinicalTrials.gov registry record · NA

ENABLE MRI (Magnetic Resonance Imaging)

A NA study, sponsored by Boston Scientific Corporation.

Completed
Registry status
NA
Development phase
500
Enrollment target

NCT02652481 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 500 participants.

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The verdict

NCT02652481, a NA study, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
NA
Development phase
500 participants
Enrollment target

Study Summary

The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled Conditions of Use (Phase I). Additionally, the study will assess medically necessary MR scans according to the labeled Conditions of Use to provide real-world scanning data (Phase I and Phase II).The study also aims to demonstrate the continued ability of the ImageReady MR Conditional Defibrillation System to sense and detect ventricular fibrillation (VF) post MRI scan by collecting and analyzing data from spontaneous VF episodes, "for-cause" VF inductions, and from an optional VF induction Sub-study. .

Interventions

  • DEVICE ImageReady MR Conditional Defibrillation System

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2016-01
Est. Completion 2018-05-04
Phase NA

Sponsor

Boston Scientific Corporation

280 total trials

What the Registry Record Tells You About NCT02652481

The ClinicalTrials.gov registry entry for NCT02652481 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ImageReady MR Conditional Defibrillation System is the first listed.

NCT02652481 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02652481 about?

NCT02652481 is a clinical study titled "ENABLE MRI (Magnetic Resonance Imaging)". The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled Conditions of Use (Phase I). Additionally, the study will assess medic...

What is the current status of trial NCT02652481?

This trial is currently completed. It is a NA study. The enrollment target is 500 participants. The study started on 2016-01. Estimated completion is 2018-05-04.

What interventions are being tested in trial NCT02652481?

The interventions under investigation include: ImageReady MR Conditional Defibrillation System (DEVICE).

Who is sponsoring clinical trial NCT02652481?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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