Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
- Conditions
- Implantable Defibrillator
- Interventions
- Device: MRI scan sequences of the head and chest regionsOther: Waiting Period Visit
- Registration Number
- NCT02117414
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
- 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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MRI Group MRI scan sequences of the head and chest regions Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant). Control Group Waiting Period Visit 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).
- Primary Outcome Measures
Name Time Method MRI-related Events 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) 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) 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.
- Secondary Outcome Measures
Name Time Method System-related Complications Implant to 4 months post-implant Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.
RV Defibrillation Impedance 1-month post-MRI/Waiting Period visit Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms
Superior Vena Cava (SVC) Defibrillation Impedance 1-month post-MRI/Waiting Period visit Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms
Atrial Pacing Capture Threshold (APCT) Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit 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.
Atrial Sensing Amplitude MRI/waiting visit to 1-month post-MRI/Waiting visit 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.
Trial Locations
- Locations (42)
Stanford Hospitals & Clinics
🇺🇸Stanford, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Central Coast Cardiology
🇺🇸Salinas, California, United States
Iowa Heart
🇺🇸West Des Moines, Iowa, United States
Mid America Heart Institute (MAHI)
🇺🇸Kansas, Missouri, United States
United Heart and Vascular Clinic
🇺🇸Saint Paul, Minnesota, United States
Park Nicollet Methodist Hospital
🇺🇸Saint Louis Park, Minnesota, United States
University of North Carolina (UNC) Memorial Hospital
🇺🇸Chapel Hill, North Carolina, United States
NYU Langone Medical Center
🇺🇸New York City, New York, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦Quebec, Canada
Centre Hospitalier Régional de la Citadelle
🇧🇪Liège, Belgium
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Hospital Clínico Pontificia Universidad Católica
🇨🇱Santiago de Chile, Chile
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Washington Hospital Center
🇺🇸Washington DC, Maryland, United States
Praxisklinik Herz und Gefässe
🇩🇪Dresden, Germany
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Azienda Ospedaliera SS Annunziata
🇮🇹Taranto, Italy
Prince Sultan Cardiac Center
🇸🇦Riyadh, Saudi Arabia
Universitätsklinikum Jena - Friedrich Schiller Universität
🇩🇪Jena, Germany
University of Calgary
🇨🇦Calgary, Alberta, Canada
DLP Upper Michigan Cardiovascular Associates PC
🇺🇸Marquette, Michigan, United States
HealthCare Partners CCNV
🇺🇸Henderson, Nevada, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
HagaZiekenhuis - Locatie Leyweg
🇳🇱Den Haag, Netherlands
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Semmelweis Egyetem AOK
🇭🇺Budapest, Hungary
Medanta-The Medicity
🇮🇳Gurgaon, India
Prairie Education & Research Cooperative (Springfield IL)
🇺🇸Springfield, Illinois, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada