Status:
COMPLETED
China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]
Lead Sponsor:
Abbott Medical Devices
Conditions:
Tachycardia
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Endpoints, and contents of clinical study Objectives: The objective of this clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators (ICDs) ...
Eligibility Criteria
Inclusion
- To participate in this clinical study, the subject must meet all of the following inclusion criteria:
- Have an approved indication for implantation of a ICD
- Be a Chinese national
- Will be implanted with one of the following device/lead combinations evaluated in this study:
- Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV)
- Group 2: Fortify Assura single-chamber ICD, with an Optisure lead
- Group 3: Ellipse DR dual-chamber ICD with a Durata lead in the RV and a Tendril STS lead in the right atrium (RA)
- Group 4: Fortify Assura ICD and an Optisure lead in the RV and an Isoflex lead in the RA
- Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
- Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
- Be willing and able to comply with the prescribed follow-up tests and procedures
- Are not contraindicated for an MRI scan (per the MRI Screening Form)
- Subjects who are at least 18 years of age (or older, required by local law)
Exclusion
- Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:
- Have a competitor's MRI compatible endocardial lead implanted or capped
- Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
- Have other non-MRI compatible device or material implanted. The following examples may be included as long as labelling of these devices allow MRI scans conducted per this protocol:
- MRI compatible knee replacements, hip replacements, stents, etc.
- MRI compatible mechanical, prosthetic, and bio prosthetic heart valves
- Non-removable dental implants
- Have a lead extender, adaptor, or capped/abandoned lead
- Enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this study as determined by Abbott.
- Pregnant or planning to become pregnant during the duration of the subject's participation in the study
- Have a life expectancy of less than 12 months due to any condition
Key Trial Info
Start Date :
March 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03828357
Start Date
March 27 2019
End Date
December 1 2020
Last Update
December 7 2023
Active Locations (1)
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1
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000