China Evera MRI® Study

NCT03261063 | Completed

• 1 other identifier: China Evera
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

• The proportion of successful MRI scans

  To summarize the MRI-related event rate within 30 days post-MRI in patients implanted with an Evera MRI device.

  1 Month Follow up visit after MRI Scan Visit

Secondary Outcomes (1)

• The effectiveness of the Evera MRI device post-MRI.

  Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.

Study Arms (1)

Evera Implanted Group

EXPERIMENTAL

Device: Evera MRI ICD System

Interventions

Evera MRI ICD System DEVICE

Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements

Evera Implanted Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 who are diagnosed with terminal disease with life expectancy less than 4 months.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (3)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Hua Xi Hospital (West China Hospital)

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: October 12, 2017
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

CN (3)