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

NCT02117414 | Completed Results

• 1 other identifier: Evera MRI
• Study Type: interventional
• Target: 275
• Locations: 13 countries
• Sites: 42

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).

Conditions

Implantable Defibrillator

Keywords

Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit

Secondary Outcomes (5)

• System-related Complications

  Implant to 4 months post-implant

• RV Defibrillation Impedance

  1-month post-MRI/Waiting Period visit

• Superior Vena Cava (SVC) Defibrillation Impedance

  1-month post-MRI/Waiting Period visit

• Atrial Pacing Capture Threshold (APCT)

  Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit

• Atrial Sensing Amplitude

  MRI/waiting visit to 1-month post-MRI/Waiting visit

Study Arms (2)

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).

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).

Other: Waiting Period Visit

Interventions

MRI scan sequences of the head and chest regions DEVICE

Non-diagnostic MRI scans

MRI Group

Waiting Period Visit OTHER

Waiting period time will equate to 1 hour

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (42)

Central Coast Cardiology

Salinas, California, 93901-3901, United States

Location

Stanford Hospitals & Clinics

Stanford, California, 94305-2200, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Orlando Health

Orlando, Florida, 32806-1215, United States

Location

Prairie Education & Research Cooperative (Springfield IL)

Springfield, Illinois, 62701-1003, United States

Location

Iowa Heart

West Des Moines, Iowa, 50266, United States

Location

Washington Hospital Center

Washington DC, Maryland, 20010, United States

Location

DLP Upper Michigan Cardiovascular Associates PC

Marquette, Michigan, 49855-5407, United States

Location

Park Nicollet Methodist Hospital

Saint Louis Park, Minnesota, 55426-4702, United States

Location

United Heart and Vascular Clinic

Saint Paul, Minnesota, 55102-2568, United States

Location

Mid America Heart Institute (MAHI)

Kansas City, Missouri, 64111, United States

Location

HealthCare Partners CCNV

Henderson, Nevada, 89052, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103-1489, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960-6136, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

University of North Carolina (UNC) Memorial Hospital

Chapel Hill, North Carolina, 27517, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195-0001, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214-3907, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104-4243, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602-2222, United States

Location

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213-2536, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425-8911, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507-1904, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Centre Hospitalier Régional de la Citadelle

Liège, Belgium

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

Hospital Clínico Pontificia Universidad Católica

Santiago, 8320000, Chile

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Praxisklinik Herz und Gefässe

Dresden, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Jena - Friedrich Schiller Universität

Jena, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Semmelweis Egyetem AOK

Budapest, Hungary

Location

Medanta-The Medicity

Gūrgaon, India

Location

Azienda Ospedaliera SS Annunziata

Taranto, Italy

Location

HagaZiekenhuis - Locatie Leyweg

The Hague, Netherlands

Location

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 27151268 DERIVED

• 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.

  PMID: 25982014 DERIVED

Results Point of Contact

• Title: Evera MRI Clinical Research Specialist
• Organization: Medtronic, Inc

medtronicCRMtrials@medtronic.com

800-328-2518

Study Officials

• Michael R Gold, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Emanuel Kanal, MD, FACR

  University of Pittsburgh Medical Center, USA

  PRINCIPAL INVESTIGATOR

• Juerg Schwitter, MD

  University Hospital Lausanne (CHUV), Switzerland

  PRINCIPAL INVESTIGATOR

• Torsten Sommer, MD

  German Red Cross Hospital (DRK) Neuwied, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 28, 2016
• Results First Posted: August 14, 2015

Record last verified: 2016-10

Locations

NL (1); BE (1); US (25); SA (1); IN (1); SE (1); HU (1); DE (4); IT (1); CH (1); CL (1); CA (3); HK (1)