Expanding MRI Access for Patients With New and Existing ICDs and CRT-Ds ( ENABLE MRI) (ENABLE MRI)
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|ClinicalTrials.gov Identifier: NCT02652481|
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : November 20, 2017
The objective of this study is to collect data to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation System when used in the 1.5T 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.
|Condition or disease||Intervention/treatment||Phase|
|Magnetic Resonance Imaging||Device: ImageReady MR Conditional Defibrillation System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||April 30, 2017|
|Estimated Study Completion Date :||December 2020|
open label - 1 arm
prospective, non-randomized, confirmatory study
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 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
- MR scan-related System Complication Free Rate (CFR) [ Time Frame: 1 Month ]MR scan-related Complication-free rate between the MR Scan and the MRI + 1 Month Visit
- Increase in RV pacing threshold [ Time Frame: 1 Month ]Increase in RV pacing threshold from the pre-MR scan to the 1 Month post-MR scan
- Increase in LV pacing threshold [ Time Frame: 1 Month ]Increase in LV pacing threshold from the pre-MR scan to the 1 Monthpost-MR scan
- Decrease in RV sensed amplitude [ Time Frame: 1 Month ]Decrease in RV sensed amplitude from the pre-MR scan to the 1 Month post-MR scan
- Decrease in LV sensed amplitude [ Time Frame: 1 Month ]Decrease in LV sensed amplitude from the pre-MR scan to the 1 Month post-MR scan
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): NCT02652481
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|Study Director:||Gregory Voss||Boston Scientific Corporation|