Status:
COMPLETED
China Evera MRI® Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.
Detailed Description
The purpose of the China Evera MRI® study is to confirm safety of the Evera MRI ICD System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Spec...
Eligibility Criteria
Inclusion
- Subjects who are indicated for implantation of an ICD at the time of study enrollment.
- Subjects who are able to undergo a pectoral implant.
- Subjects who are able and willing to undergo elective MRI scanning without sedation , .
- Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
- Subjects who are at least 18 years of age (or older, if required by local law).
Exclusion
- Subjects with a history of significant tricuspid valvular disease that precludes the ability to place the RV lead. .
- Subjects who may be contraindicated to the dexamethasone sodium phosphate and/or dexamethasone acetate.
- Subjects who require a legally authorized representative to obtain informed consent.
- Subjects with abandoned or capped leads.
- Subjects who require an indicated MRI scan, other than those specifically described in the China Evera MRI® study, before the one-month post-MRI follow-up (approximately 4 months post-implant).
- Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
- Subjects with medical conditions that preclude the testing required by the CIP or limit study participation.
- Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the China Evera MRI® study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
- Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant
- Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).
- Subjects who are diagnosed with terminal disease with life expectancy less than 4 months.
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03261063
Start Date
October 12 2017
End Date
September 26 2018
Last Update
October 15 2018
Active Locations (3)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
2
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
3
Hua Xi Hospital (West China Hospital)
Chengdu, Sichuan, China, 610041