Status:
COMPLETED
Observation of ImageReady™ MR Conditional Defibrillation System in China
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.
Detailed Description
This is a multi-center, prospective, single-arm study, aimed to observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.It will enroll 20 subje...
Eligibility Criteria
Inclusion
- Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology
- Subject must have the ImageReady System as their initial (de novo) defibrillation system implant
- Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD
- Subject is able and willing to undergo an MR scan
- Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
- Subject is age 18 or above
Exclusion
- Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders
- Presence of metallic objects that represent a contraindication to MR imaging at the discretion of the Radiologist and impacting the ability to conduct the study protocol
- Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit
- Subject with:
- A history of syncope related to brady-arrhythmia
- A history of syncope of unknown etiology
- Sinus pauses (Pause \> 2 s)
- Permanent or intermittent complete AV block
- Documentation of progressive AV nodal block over time
- Trifascicular block (alternating bundle branch block or PR \> 200 ms with LBBB or other bifascicular block)
- Note: It is required to run a 12 lead ECG and a 10s rhythm strip to document this exclusion criterion.
- Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy support in a supine position for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
- Subject is not clinically capable of tolerating the absence of Tachycardia therapy support for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
- Subjects currently requiring dialysis
- Subject has a mechanical heart valve
- Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
- Subject is currently on the active heart transplant list
- Subject has documented life expectancy of less than 12 months
- Subject is enrolled in any other concurrent study that might interfere with this study
- Women of childbearing potential who are or might be pregnant at the time of this study
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03451721
Start Date
April 3 2018
End Date
December 10 2019
Last Update
November 1 2021
Active Locations (1)
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1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032