CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 500 enrolled
Drug / intervention
ImageReady MR Conditional Defibrillation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02652481
NCT02652481N/ACompleted
CompareCT.gov

Expanding MRI (Magnetic Resonance Imaging) Access for Patients With New and Existing ICDs (Implantable Cardioverter Defibrillator) and CRT-Ds (Cardiac Resynchronization Therapy Defibrillator)

Boston Scientific Corporation·interventional·Posted Jan 12, 2016·Updated Jan 25, 2021

In Brief

A clinical study evaluating ImageReady MR Conditional Defibrillation System for Magnetic Resonance Imaging. Completed, enrolled 500 participants across 57 sites in 9 countries.

Detailed 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. .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMagnetic Resonance Imaging
CountriesBelgium, Germany, Hong Kong, Israel, Italy, Malaysia, Spain, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 12, 2016
Enrollment StartJan 1, 2016
Primary CompletionApr 30, 2017
Study CompletionMay 4, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.5 years ago

Interventions

ImageReady MR Conditional Defibrillation Systemdevice

ImageReady MR Conditional Defibrillation System Components: Device Name Device Model Number Pulse Generators Phase I and II Phase II Only \* CRT-D (IS1/DF4/IS4) VR ICD (DF4) DR ( dual chamber) ICD (IS1/DF4) ORIGEN™ MINI ICD ORIGEN EL ICD ORIGEN X4 CRT INOGEN™ MINI ICD INOGEN EL ICD INOGEN X4 CRT DYNAGEN™ MINI ICD DYNAGEN EL ICD DYNAGEN X4 CRT-D AUTOGEN ™ MINI ICD\* AUTOGEN EL ICD\* AUTOGEN X4 CRT-D\* Right Atrial Leads and Accessories FINELINE™ II Sterox FINELINE II Sterox EZ Suture Sleeves for FINELINE II Leads INGEVITY™ MRI\* Suture Sleeve for INGEVITY MRI\* IS-1 Lead Port Plug 7145 Right Ventricular Leads and Accessories RELIANCE 4-FRONT™ (DF4)\* Suture Sleeve for RELIANCE 4-FRONT leads\*; ENDOTAK RELIANCE™ (DF4) Left Ventricular Leads and Accessories ACUITY™ X4 (IS4) Suture Sleeve for ACUITY X4 leads \* May only be used internationally outside the US