A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study (MRI Ready IDE)
|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: NCT02787291|
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : September 3, 2020
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Implantable Defibrillator User||Device: Ellipse VR ICD and Durata/Optisure lead||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||227 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||January 12, 2017|
|Actual Study Completion Date :||April 11, 2018|
Ellipse VR ICD and Durata/Optisure lead
Pts with Ellipse VR ICD and Durata or Optisure RV lead implanted for at least 60 days will receive a non-diagnostic MRI scan of head and chest region
Device: Ellipse VR ICD and Durata/Optisure lead
Non-diagnostic MRI Scan sequence of head and chest
- Number of Participants With MRI Scan Related Complications [ Time Frame: MRI scan to 1 month post MRI scan ]The primary safety endpoint is the number of participants that had an Ellipse ICD and/or a Durata or Optisure lead complication from the day the MRI scan occurred to the 1-month visit. A complication is defined as a serious adverse device effect that requires an invasive intervention or leads to death.
- Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V [ Time Frame: pre-MRI scan to 1 month post MRI scan ]Percentage of participants of Durata or Optisure (RV) leads implanted with the Ellipse VR ICD with capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1 month post-MRI scan.
- Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan [ Time Frame: pre-MRI scan to 1 month post MRI scan ]Percentage of Participants with Durata or Optisure RV leads implanted with the Ellipse VR ICD with sensing amplitude decrease of ≤ 50% from pre-MRI scan to 1 month post MRI 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): NCT02787291
|Study Chair:||Saman Nazarian, MD||Johns Hopkins University Hospital|