Implantable DefibrillatorNCT02117414

Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access

A study testing MRI scan sequences of the head and chest regions and Waiting Period Visit in people with Implantable Defibrillator, run by Medtronic Cardiac Rhythm and Heart Failure at 42 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Implantable Defibrillator
What is being tested?: MRI scan sequences of the head and chest regions and Waiting Period Visit
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 275 participants
Where: 42 sitesin 13 countries
Study dates: Apr 2014to Sep 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 receiving an ICD for the first time.
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 .
Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate and/or dexamethasone acetate may be contraindicated.
Subjects who require a legally authorized representative to obtain informed consent.
Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead or device revisions.
Subjects with abandoned or capped leads.
Subjects who require an indicated MRI scan, other than those specifically described in the Evera MRI™ study, before the one-month post-MRI/waiting period follow-up (approximately 4 months post-implant).

Show all 11Show fewer

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 study protocol 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 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).

Trial locations and contacts

42 sites in 13 countries.

Country

City, postcode or hospital

42 sites in 13 countries

United States25 sites

Cooper University Hospital
Camden, New Jersey, 08103-1489
University of North Carolina (UNC) Memorial Hospital
Chapel Hill, North Carolina, 27517
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425-8911
Carolinas Medical Center
Charlotte, North Carolina, 28203
Cleveland Clinic
Cleveland, Ohio, 44195-0001
OhioHealth Research Institute
Columbus, Ohio, 43214-3907
Hartford Hospital
Hartford, Connecticut, 06102
HealthCare Partners CCNV
Henderson, Nevada, 89052
Mid America Heart Institute (MAHI)
Kansas City, Missouri, 64111
Lancaster General Hospital
Lancaster, Pennsylvania, 17602-2222
DLP Upper Michigan Cardiovascular Associates PC
Marquette, Michigan, 49855-5407
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53233
Morristown Memorial Hospital
Morristown, New Jersey, 07960-6136
NYU Langone Medical Center
New York, New York, 10016
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507-1904
Orlando Health
Orlando, Florida, 32806-1215
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213-2536
Park Nicollet Methodist Hospital
Saint Louis Park, Minnesota, 55426-4702
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102-2568
Central Coast Cardiology
Salinas, California, 93901-3901
Prairie Education & Research Cooperative (Springfield IL)
Springfield, Illinois, 62701-1003
Stanford Hospitals & Clinics
Stanford, California, 94305-2200
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104-4243
Washington Hospital Center
Washington DC, Maryland, 20010
Iowa Heart
West Des Moines, Iowa, 50266

Other trials in United States

Germany4 sites

Universitätsklinikum Bonn
Bonn
Praxisklinik Herz und Gefässe
Dresden
Medizinische Hochschule Hannover
Hanover
Universitätsklinikum Jena - Friedrich Schiller Universität
Jena

Other trials in Germany

Canada3 sites

University of Calgary
Calgary, Alberta, T2N 4N1
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5

Other trials in Canada

Belgium1 site

Centre Hospitalier Régional de la Citadelle
Liège

Other trials in Belgium

Chile1 site

Hospital Clínico Pontificia Universidad Católica
Santiago, 8320000

Other trials in Chile

Hong Kong1 site

Queen Mary Hospital
Hong Kong

Other trials in Hong Kong

Hungary1 site

Semmelweis Egyetem AOK
Budapest

Other trials in Hungary

India1 site

Medanta-The Medicity
Gūrgaon

Other trials in India

Italy1 site

Azienda Ospedaliera SS Annunziata
Taranto

Other trials in Italy

Netherlands1 site

HagaZiekenhuis - Locatie Leyweg
The Hague

Other trials in Netherlands

Saudi Arabia1 site

Prince Sultan Cardiac Center
Riyadh

Other trials in Saudi Arabia

Sweden1 site

Akademiska Sjukhuset
Uppsala

Other trials in Sweden

Switzerland1 site

Centre Hospitalier Universitaire Vaudois
Lausanne

Other trials in Switzerland

About this study

Official title: Evera MRI Clinical Study

Conditions: Implantable Defibrillator
Being tested: MRI scan sequences of the head and chest regions, Waiting Period Visit
Keywords: Magnetic Resonance Imaging (MRI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRI scan sequences of the head and chest regionsDevice
Non-diagnostic MRI scans
Waiting Period VisitOther
Waiting period time will equate to 1 hour

Study groups in NCT02117414
Study group	Role	What they receive
MRI Group	Experimental	Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant). Receives: Device: MRI scan sequences of the head and chest regions
Control Group	Sham comparator	Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant). Receives: Other: Waiting Period Visit

What is being measured

The primary outcome is the main question the study is designed to answer.

MRI-related Events
Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.
Measured: MRI procedure to 1-month post-MRI
Ventricular Pacing Capture Threshold (VPCT)
Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.
Measured: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Ventricular Sensing Amplitude (R-wave)
Number of successful patients who do not experience a decrease in ventricular sensing amplitude of >50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value <3mV accompanied by a decrease of >25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.
Measured: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit

Secondary outcomes (5)

System-related Complications
Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.
Measured: Implant to 4 months post-implant
RV Defibrillation Impedance
Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms
Measured: 1-month post-MRI/Waiting Period visit
Superior Vena Cava (SVC) Defibrillation Impedance
Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms
Measured: 1-month post-MRI/Waiting Period visit
Atrial Pacing Capture Threshold (APCT)
Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post.
Measured: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Atrial Sensing Amplitude
Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post.
Measured: MRI/waiting visit to 1-month post-MRI/Waiting visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Sep 2015

First posted21 Apr 2014 (estimated)
Study startApr 2014
Primary completionJan 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Implantable DefibrillatorStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02117414
Sponsor's protocol ID: Evera MRI
Status last verified: Oct 2016
First submitted: 16 Apr 2014
Last updated: 28 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schwitter J, Gold MR, Al Fagih A, Lee S, Peterson M, Ciuffo A, Zhang Y, Kristiansen N, Kanal E, Sommer T; Evera-MRI Study Investigators. Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment. Circ Cardiovasc Imaging. 2016 May;9(5):e004025. doi: 10.1161/CIRCIMAGING.115.004025.
PubMed 27151268
Gold MR, Sommer T, Schwitter J, Al Fagih A, Albert T, Merkely B, Peterson M, Ciuffo A, Lee S, Landborg L, Cerkvenik J, Kanal E; Evera MRI Study Investigators. Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator: Primary Results of a Randomized Study. J Am Coll Cardiol. 2015 Jun 23;65(24):2581-2588. doi: 10.1016/j.jacc.2015.04.047. Epub 2015 May 14.
PubMed 25982014

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evera MRI Clinical Study
ClinicalTrials.gov ID: NCT02117414
Acronym / sponsor ID: Evera MRI
Conditions: Implantable Defibrillator
Keywords: Magnetic Resonance Imaging (MRI)
Study type: Interventional
Recruitment status: Completed
Enrolment: 275 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jan 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 21 Apr 2014 (estimated)
Results: Posted 14 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MRI Group	Experimental	Device: MRI scan sequences of the head and chest regionsSubjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
Control Group	Sham comparator	Other: Waiting Period VisitSubjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 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 receiving an ICD for the first time.
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.

Key exclusion criteria (11 listed)

Subjects with a history of significant tricuspid valvular disease .
Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate and/or dexamethasone acetate may be contraindicated.
Subjects who require a legally authorized representative to obtain informed consent.
Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead or device revisions.
Subjects with abandoned or capped leads.

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
MRI scan sequences of the head and chest regionsNon-diagnostic MRI scans	Device	MRI Group
Waiting Period VisitWaiting period time will equate to 1 hour	Other	Control Group

Primary outcome

MRI-related Events
Time frame: MRI procedure to 1-month post-MRI
Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.
Ventricular Pacing Capture Threshold (VPCT)
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.
Ventricular Sensing Amplitude (R-wave)
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Number of successful patients who do not experience a decrease in ventricular sensing amplitude of >50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value <3mV accompanied by a decrease of >25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.

5 secondary outcomes

System-related Complications
Time frame: Implant to 4 months post-implant
RV Defibrillation Impedance
Time frame: 1-month post-MRI/Waiting Period visit
Superior Vena Cava (SVC) Defibrillation Impedance
Time frame: 1-month post-MRI/Waiting Period visit
Atrial Pacing Capture Threshold (APCT)
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Atrial Sensing Amplitude
Time frame: MRI/waiting visit to 1-month post-MRI/Waiting visit

Results and safety

Results posted to the registry on 14 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRI Group	175	160
Control Group	88	82

Primary outcome: MRI-related Events

Time frame: MRI procedure to 1-month post-MRI. Number. Unit: Participants free of MRI-related events

Measure	MRI Group n = 147
Value	147

MRI Group: Percentage: 100, p <0.0001, one-proportion binomial exact test

Population analysed: A total of 156 subjects underwent an MRI scan at the MRI/waiting period visit; of them 147 were followed through the one month post-MRI visit or later and are included in the analysis.

Primary outcome: Ventricular Pacing Capture Threshold (VPCT)

Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit. Number. Unit: Successful participants

Measure	MRI Group n = 154	Control Group n = 81
Value	154	80

MRI Group vs Control Group: Difference in percentages: 1.2, p <0.0001, Farrington-Manning non-inferiority test

Population analysed: To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid VPCT measurements pre-MRI/waiting period and post-MRI/waiting period.

Primary outcome: Ventricular Sensing Amplitude (R-wave)

Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit. Number. Unit: Successful participants

Measure	MRI Group n = 153	Control Group n = 82
Value	152	81

MRI Group vs Control Group: Difference in percentages: 0.6, p = 0.0001, Farrington-Manning non-inferiority test

Population analysed: Only subjects with measured ventricular sensing amplitude values both pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI Group	35 of 175 (20%)	0 of 175 (0%)	Not reported
Control Group	15 of 88 (17%)	0 of 88 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27151268Schwitter J, Gold MR, Al Fagih A, Lee S, Peterson M, Ciuffo A, Zhang Y, Kristiansen N, Kanal E, Sommer T; Evera-MRI Study Investigators. Image Quality of Cardiac Magnetic Resonance Imaging in Patients With an Implantable Cardioverter Defibrillator System Designed for the Magnetic Resonance Imaging Environment. Circ Cardiovasc Imaging. 2016 May;9(5):e004025. doi: 10.1161/CIRCIMAGING.115.004025.
Derived from this study: PubMed 25982014Gold MR, Sommer T, Schwitter J, Al Fagih A, Albert T, Merkely B, Peterson M, Ciuffo A, Lee S, Landborg L, Cerkvenik J, Kanal E; Evera MRI Study Investigators. Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator: Primary Results of a Randomized Study. J Am Coll Cardiol. 2015 Jun 23;65(24):2581-2588. doi: 10.1016/j.jacc.2015.04.047. Epub 2015 May 14.

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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.

Michael R Gold, MD, PhD principal investigator

Medical University of South Carolina

Emanuel Kanal, MD, FACR principal investigator

University of Pittsburgh Medical Center, USA

Juerg Schwitter, MD principal investigator

University Hospital Lausanne (CHUV), Switzerland

42 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Germany, Canada, Belgium, Chile and 8 more countries. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 14 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

MRI-related Events (time frame: MRI procedure to 1-month post-MRI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117414, which also lists 2 linked publications.

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 28 Nov 2016.