China Evera MRI® Study

NCT ID: NCT03261063

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-12
• Study Completion Date: 2018-09-26

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 Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body). Long-term device effects, such as long-term lead integrity, will not be assessed in the China Evera MRI® study.

Conditions

Arrhythmias, Cardiac

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Evera Implanted Group

Group Type: EXPERIMENTAL

Evera MRI ICD System

Intervention Type: DEVICE

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

Interventions

Evera MRI ICD System

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Hua Xi Hospital (West China Hospital)

Chengdu, Sichuan, China

Countries

China

Other Identifiers

China Evera

Identifier Type: -

Identifier Source: org_study_id