| CTRI Number |
CTRI/2014/07/004787 [Registered on: 30/07/2014] Trial Registered Prospectively |
| Last Modified On: |
22/05/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Evera MRIâ„¢ Study - To confirm safety and efficacy of the Evera MRIâ„¢, an implantable cardioverter defibrillator System when subjects implanted with the device receive MRI scans |
|
Scientific Title of Study
|
Evera MRIâ„¢ Study |
| Trial Acronym |
EVERA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT02117414 |
ClinicalTrials.gov |
| Version 1, 20 OCT 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Haresh Sachanandani |
| Designation |
Clinical Research Supervisor |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
1241, Solitaire Corporate Park,
Building No 12, 4th Floor,
Andheri-Ghatkopar Link Road, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400093
India |
| Phone |
7738096120 |
| Fax |
|
| Email |
haresh.g.sachanandani@medtronic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Haresh Sachanandani |
| Designation |
Clinical Research Supervisor |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
1241, Solitaire Corporate Park,
Building No 12, 4th Floor,
Andheri-Ghatkopar Link Road, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400093
India |
| Phone |
7738096120 |
| Fax |
|
| Email |
haresh.g.sachanandani@medtronic.com |
|
Details of Contact Person
Public Query
|
| Name |
Haresh Sachanandani |
| Designation |
Clinical Research Supervisor |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
1241, Solitaire Corporate Park,
Building No 12, 4th Floor,
Andheri-Ghatkopar Link Road, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400093
India |
| Phone |
7738096120 |
| Fax |
|
| Email |
haresh.g.sachanandani@medtronic.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medtronic Inc |
| Address |
Medtronic World Headquarters Campus
710 Medtronic Parkway
|
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Canada
Central African Republic
China
India
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Sridevi |
CARE Hospital |
Department of Clinical Research
1st Floor, Kanakam Building, Opposite Manojs Homeopathy,
H No: 6-3-248/3/5/8 Flat No. 8, Banjara Avenue,
Banjarahills,Road No.1,
Hyderabad- 500034
Hyderabad
ANDHRA PRADESH |
9866101054
dr_csridevi@yahoo.com |
| Dr Balbir Singh |
Medanta - The Medicity |
Sector 38, Gurgaon, Haryana - 122001
Gurgaon
HARYANA |
9910314792
krishan.sharma@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Care Hospital |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Subjects who are indicated for implantation of an ICD at the time of study
enrollment.
o Subjects who are able to undergo a pectoral implant., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evera MRIâ„¢ Study System |
Evera MRIâ„¢ DR/VR SureScanâ„¢ implantable cardioverter defibrillator (ICD) will be
referred to as Evera MRIâ„¢ ICD |
| Comparator Agent |
Not Applicable |
No Comparator Agent in this study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are indicated for implantation of an ICD at the time of study
enrollment.
o Subjects who are able to undergo a pectoral implant.
o Subjects who are receiving an ICD for the first time.
o Subjects who are able and willing to undergo elective MRI scanning without
sedation.7,8
o 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) |
|
| ExclusionCriteria |
| Details |
Subjects with a history of significant tricuspid valvular disease9.
o Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate
and/or dexamethasone acetate may be contraindicated.
o Subjects who require a legally authorized representative to obtain informed
consent.
o Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead
or device revisions.
o Subjects with abandoned or capped leads.
o Subjects who require an indicated MRI scan, other than those specifically
described in the Evera MRIâ„¢ study, before the one-month post-MRI/waiting
period follow-up (approximately 4 months post-implant).
o 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).
o Subjects with medical conditions that preclude the testing required by the CIP or
limit study participation.
o 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
Evera MRIâ„¢ study. Co-enrollment in concurrent trials is only allowed when
documented pre-approval is obtained from the Medtronic study manager.
o 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.10
o Subjects with exclusion criteria required by local law (e.g., age, breastfeeding). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety
o To demonstrate an acceptable MRI-related event-free rate.
Efficacy
o To demonstrate that the proportion of patients whose ventricular pacing capture
threshold increases significantly one month post-MRI/waiting period is similar
between the MRI group and the control group. |
After 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To demonstrate an acceptable system-related complication rate.
o To demonstrate the system integrity of the high-voltage ICD component after MRI
exposure.
o To demonstrate that the proportion of patients whose atrial pacing capture
threshold increases significantly one month post-MRI/waiting period is similar
between the MRI group and the control group. |
2 montha and 6-months after Implant |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/08/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/04/2014 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
No publication presently |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Medtronic, Inc. is sponsoring the Evera MRIâ„¢ study. This study is a prospective, randomized
controlled, non-blinded, multi-site worldwide study. The purpose of the Evera MRIâ„¢ study is to
confirm safety and efficacy of the Evera MRIâ„¢ 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). The data collected in the Evera MRIâ„¢ study may be used to support regulatory
submissions for the U.S. and other geographies that require human clinical trial data in order to
obtain market approval for devices or labeling changes for the system or its successors. Longterm
device effects, such as long-term lead integrity, will not be assessed in the Evera MRIâ„¢
study. |