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China Evera MRI® Study

Primary Purpose

Arrhythmias, Cardiac

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Evera MRI ICD System
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmias, Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Third Xiangya Hospital of Central South University
  • Zhongshan Hospital
  • Hua Xi Hospital (West China Hospital)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evera Implanted Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 22, 2017
Last Updated
October 12, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT03261063
Brief Title
China Evera MRI® Study
Official Title
China Evera MRI® Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
September 26, 2018 (Actual)
Study Completion Date
September 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evera Implanted Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Evera MRI ICD System
Intervention Description
Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements
Primary Outcome Measure Information:
Title
The proportion of successful MRI scans
Description
To summarize the MRI-related event rate within 30 days post-MRI in patients implanted with an Evera MRI device.
Time Frame
1 Month Follow up visit after MRI Scan Visit
Secondary Outcome Measure Information:
Title
The effectiveness of the Evera MRI device post-MRI.
Description
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.
Time Frame
Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Hua Xi Hospital (West China Hospital)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

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China Evera MRI® Study

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