China Evera MRI® Study

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

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: Evera MRI ICD System

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Hua Xi Hospital (West China Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evera Implanted Group	Device: Evera MRI ICD System; Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effectiveness of the Evera MRI device post-MRI.	The effectiveness of the Evera MRI device will be measured by the following parameters; Atrial pacing capture threshold (only for dual chamber devices); Atrial sensing amplitude (only for dual chamber devices); Ventricular pacing capture threshold; Ventricular sensing amplitude These parameters will be measured pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.	Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Actual): September 26, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: China Evera

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No