Clinical trial NCT02117414: Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
Official title: Evera MRI Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Defibrillator
Keywords: Magnetic Resonance Imaging (MRI)
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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 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).

Exclusion Criteria:

* 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).
* 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).

Primary outcomes:
measure: MRI-related Events
timeFrame: MRI procedure to 1-month post-MRI
measure: Ventricular Pacing Capture Threshold (VPCT)
timeFrame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
measure: Ventricular Sensing Amplitude (R-wave)
timeFrame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Secondary outcomes:
measure: System-related Complications
timeFrame: Implant to 4 months post-implant
measure: RV Defibrillation Impedance
timeFrame: 1-month post-MRI/Waiting Period visit
measure: Superior Vena Cava (SVC) Defibrillation Impedance
timeFrame: 1-month post-MRI/Waiting Period visit
measure: Atrial Pacing Capture Threshold (APCT)
timeFrame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
measure: Atrial Sensing Amplitude
timeFrame: MRI/waiting visit to 1-month post-MRI/Waiting visit
Other outcomes:
Locations:
city: Salinas
country: United States
facility: Central Coast Cardiology
state: California
city: Stanford
country: United States
facility: Stanford Hospitals & Clinics
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative (Springfield IL)
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Heart
state: Iowa
city: Washington DC
country: United States
facility: Washington Hospital Center
state: Maryland
city: Marquette
country: United States
facility: DLP Upper Michigan Cardiovascular Associates PC
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicollet Methodist Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Kansas
country: United States
facility: Mid America Heart Institute (MAHI)
state: Missouri
city: Henderson
country: United States
facility: HealthCare Partners CCNV
state: Nevada
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New York City
country: United States
facility: NYU Langone Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) Memorial Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
city: Santiago de Chile
country: Chile
facility: Hospital Clínico Pontificia Universidad Católica
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefässe
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Universitätsklinikum Jena - Friedrich Schiller Universität
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Gurgaon
country: India
facility: Medanta-The Medicity
city: Taranto
country: Italy
facility: Azienda Ospedaliera SS Annunziata
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis - Locatie Leyweg
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Medical University of South Carolina
name: Michael R Gold, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center, USA
name: Emanuel Kanal, MD, FACR
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Lausanne (CHUV), Switzerland
name: Juerg Schwitter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Red Cross Hospital (DRK) Neuwied, Germany
name: Torsten Sommer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.