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

Implantable Defibrillator Clinical Trial

Official title:

Evera MRI Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02117414
• Other study ID #: Evera MRI
• Status: Active, not recruiting
• Phase: N/A
• First received: April 16, 2014
• Last updated: July 20, 2015
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2015
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 275
• Est. completion date: October 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Implantable Defibrillator

Intervention

Device:
• MRI scan sequences of the head and chest regions
Non-diagnostic MRI scans

Other:
• Waiting Period Visit
Waiting period time will equate to 1 hour

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Régional de la Citadelle	Liège
Canada	University of Calgary	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Quebec
Chile	Hospital Clínico Pontificia Universidad Católica	Santiago de Chile
Germany	Universitätsklinikum Bonn	Bonn
Germany	Praxisklinik Herz und Gefässe	Dresden
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Jena - Friedrich Schiller Universität	Jena
Hong Kong	Queen Mary Hospital	Hong Kong
Hungary	Semmelweis Egyetem AOK	Budapest
India	Medanta-The Medicity	Gurgaon
Italy	Azienda Ospedaliera SS Annunziata	Taranto
Netherlands	HagaZiekenhuis - Locatie Leyweg	Den Haag
Saudi Arabia	Prince Sultan Cardiac Center	Riyadh
Sweden	Akademiska Sjukhuset	Uppsala
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United States	Cooper University Hospital	Camden	New Jersey
United States	University of North Carolina (UNC) Memorial Hospital	Chapel Hill	North Carolina
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Hartford Hospital	Hartford	Connecticut
United States	HealthCare Partners CCNV	Henderson	Nevada
United States	Mid America Heart Institute (MAHI)	Kansas	Missouri
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	DLP Upper Michigan Cardiovascular Associates PC	Marquette	Michigan
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	NYU Langone Medical Center	New York City	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Orlando Health	Orlando	Florida
United States	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	Park Nicollet Methodist Hospital	Saint Louis Park	Minnesota
United States	United Heart and Vascular Clinic	Saint Paul	Minnesota
United States	Central Coast Cardiology	Salinas	California
United States	Prairie Education & Research Cooperative (Springfield IL)	Springfield	Illinois
United States	Stanford Hospitals & Clinics	Stanford	California
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Washington Hospital Center	Washington DC	Maryland
United States	Iowa Heart	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Chile,  Germany,  Hong Kong,  Hungary,  India,  Italy,  Netherlands,  Saudi Arabia,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI-related Events	Percentage 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	No
Primary	Ventricular Pacing Capture Threshold (VPCT)	Percentage 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	No
Primary	Ventricular Sensing Amplitude (R-wave)	Percentage 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	No
Secondary	System-related Complications	Percentage of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.	Implant to 4 months post-implant	No
Secondary	RV Defibrillation Impedance	% of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms	1-month post-MRI/Waiting Period visit	No
Secondary	Superior Vena Cava (SVC) Defibrillation Impedance	% of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms	1-month post-MRI/Waiting Period visit	No
Secondary	Atrial Pacing Capture Threshold (APCT)	Percentage of successful patients, where success is defined as not increasing APCT 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	No
Secondary	Atrial Sensing Amplitude	Percentage 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.	MRI/waiting visit to 1-month post-MRI/Waiting visit	No