Arrhythmias, CardiacNCT03261063
China Evera MRI® Study
A study testing Evera MRI ICD System in people with Arrhythmias, Cardiac, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in China.
Trial summary
The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Evera MRI ICD System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesChina
- Study dates
- 12 Oct 2017to 26 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Hua Xi Hospital (West China Hospital)
Chengdu, Sichuan, 610041
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
About this study
The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.
Read the 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
- Being tested
- Evera MRI ICD System
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evera MRI ICD SystemDevice
Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements
| Study group | Role | What they receive |
|---|---|---|
| Evera Implanted Group | Experimental | Not described Receives: Device: Evera MRI ICD System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month Follow up visit after MRI Scan Visit
Secondary outcomes (1)
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.
Measured: Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start12 Oct 2017
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261063
- Sponsor's protocol ID
- China Evera
- Status last verified
- Oct 2018
- First submitted
- 22 Aug 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Evera MRI® Study
- ClinicalTrials.gov ID
- NCT03261063
- Acronym / sponsor ID
- China Evera
- Conditions
- Arrhythmias, Cardiac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evera Implanted Group | Experimental | Device: Evera MRI ICD System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evera MRI ICD SystemSubjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements | Device | Evera Implanted Group |
Primary outcome
The proportion of successful MRI scans
Time frame: 1 Month Follow up visit after MRI Scan Visit
To summarize the MRI-related event rate within 30 days post-MRI in patients implanted with an Evera MRI device.
1 secondary outcome
The effectiveness of the Evera MRI device post-MRI.
Time frame: Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evera MRI ICD System in people with Arrhythmias, Cardiac, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of successful MRI scans (time frame: 1 Month Follow up visit after MRI Scan Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.