MedTrace Logo

ENABLE MRI (Magnetic Resonance Imaging)

NCT02652481 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-01-25

Study results available
· View outcomes & findings →

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.

.

Conditions

  • Magnetic Resonance Imaging

Interventions

DEVICE

ImageReady MR Conditional Defibrillation System

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Gregory Voss · Boston Scientific Corporation

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-04-30
Completion
2018-05-04
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Malaysia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652481 on ClinicalTrials.gov