CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Study MRI scanother
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/NCT03828357
NCT03828357N/ACompleted
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The Evaluation of ICD Defibrillation Systems in a 1.5T Magnetic Resonance Imaging Environment in China

Abbott Medical Devices·observational·Posted Feb 4, 2019·Updated Dec 7, 2023

In Brief

An observational study evaluating Study MRI scan for Tachycardia. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI environment for MR-conditional labeling expansion of these market-approved ICD/CRT-D systems in China. Note: Protocol updated: Fortify Assura VR/DR ICD removed; Quadra Assura MP CRT-D and Quartet leads added. The Detailed Description Section below was updated upon protocol amendment.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTachycardia
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 4, 2019
Enrollment StartMar 27, 2019
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.4 years ago

Interventions

Study MRI scanother

At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.