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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI scan sequences of the head and chest regions | Device | Non-diagnostic MRI scans |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| System-related Complications | Number 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 |
| RV Defibrillation Impedance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Coast Cardiology | Salinas | California | 93901-3901 | United States | ||
| Stanford Hospitals & Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27151268 | Derived | 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. | |
| 25982014 |
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A successful implant was defined as having received a complete Evera MRI™ Study System (Evera MRI™ DR or VR ICD, one Model 6935M or 6947M lead, and one Model 5076 lead (if DR system)). Eleven subjects did not have an implant attempt and one subject did not have a successful implant. None of these subjects were randomized.
A total of 275 subjects were enrolled (consented) at 42 centers in the Evera MRI study. The first enrollment occurred on April 17, 2014, and the last enrollment occurred on September 11, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI Group | Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant). MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans |
| FG001 | Control Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Waiting Period Visit |
| Other |
Waiting period time will equate to 1 hour |
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Number 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 |
| 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 | 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. | 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. | MRI/waiting visit to 1-month post-MRI/Waiting visit |
| Stanford |
| California |
| 94305-2200 |
| United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Orlando Health | Orlando | Florida | 32806-1215 | United States |
| Prairie Education & Research Cooperative (Springfield IL) | Springfield | Illinois | 62701-1003 | United States |
| Iowa Heart | West Des Moines | Iowa | 50266 | United States |
| Washington Hospital Center | Washington DC | Maryland | 20010 | United States |
| DLP Upper Michigan Cardiovascular Associates PC | Marquette | Michigan | 49855-5407 | United States |
| Park Nicollet Methodist Hospital | Saint Louis Park | Minnesota | 55426-4702 | United States |
| United Heart and Vascular Clinic | Saint Paul | Minnesota | 55102-2568 | United States |
| Mid America Heart Institute (MAHI) | Kansas City | Missouri | 64111 | United States |
| HealthCare Partners CCNV | Henderson | Nevada | 89052 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103-1489 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07960-6136 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| University of North Carolina (UNC) Memorial Hospital | Chapel Hill | North Carolina | 27517 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195-0001 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214-3907 | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104-4243 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602-2222 | United States |
| University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213-2536 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425-8911 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507-1904 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53233 | United States |
| Centre Hospitalier Régional de la Citadelle | Liège | Belgium |
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) | Québec | Quebec | G1V 4G5 | Canada |
| Hospital Clínico Pontificia Universidad Católica | Santiago | 8320000 | Chile |
| Universitätsklinikum Bonn | Bonn | Germany |
| Praxisklinik Herz und Gefässe | Dresden | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Universitätsklinikum Jena - Friedrich Schiller Universität | Jena | Germany |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Semmelweis Egyetem AOK | Budapest | Hungary |
| Medanta-The Medicity | Gurgaon | India |
| Azienda Ospedaliera SS Annunziata | Taranto | Italy |
| HagaZiekenhuis - Locatie Leyweg | The Hague | Netherlands |
| Prince Sultan Cardiac Center | Riyadh | Saudi Arabia |
| Akademiska Sjukhuset | Uppsala | Sweden |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| 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. |
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).
Waiting Period Visit: Waiting period time will equate to 1 hour
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI Group | Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant). MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans |
| BG001 | Control Group | 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). Waiting Period Visit: Waiting period time will equate to 1 hour |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Participants free of MRI-related events | MRI procedure to 1-month post-MRI |
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| Primary | 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. | 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. | Posted | Number | Successful participants | Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit |
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| Primary | 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. | Only subjects with measured ventricular sensing amplitude values both pre-MRI/waiting period and post-MRI/waiting period were used in the analysis. | Posted | Number | Successful participants | Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit |
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| Secondary | System-related Complications | Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it. | All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis. | Posted | Number | Successful participants | Implant to 4 months post-implant |
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| Secondary | 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 | Only randomized subjects with measured RV defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an RV defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated. | Posted | Number | Successful participants | 1-month post-MRI/Waiting Period visit |
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| Secondary | 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 | Only randomized subjects with measured SVC defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated. | Posted | Number | Successful participants | 1-month post-MRI/Waiting Period visit |
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| Secondary | 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. | 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 APCT measurements pre-MRI/waiting period and post-MRI/waiting period. | Posted | Number | Successful participants | Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit |
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| Secondary | 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. | Only subjects with measured atrial sensing amplitude values at both the pre-MRI/waiting period and post-MRI/waiting period were used in the analysis. | Posted | Number | Successful participants | MRI/waiting visit to 1-month post-MRI/Waiting visit |
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The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI Group | Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant). MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans | 35 | 175 | 0 | 175 | ||
| EG001 | Control Group | 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). Waiting Period Visit: Waiting period time will equate to 1 hour | 15 | 88 | 0 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA |
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| Acute myocardial infarction | Cardiac disorders | MedDRA |
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| Angina pectoris | Cardiac disorders | MedDRA |
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| Angina unstable | Cardiac disorders | MedDRA |
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| Atrial flutter | Cardiac disorders | MedDRA |
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| Cardiac arrest | Cardiac disorders | MedDRA |
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| Cardiac failure | Cardiac disorders | MedDRA |
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| Cardiac failure congestive | Cardiac disorders | MedDRA |
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| Cardiac perforation | Cardiac disorders | MedDRA |
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| Cardiac tamponade | Cardiac disorders | MedDRA |
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| Cardiogenic shock | Cardiac disorders | MedDRA |
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| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA |
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| Pericardial effusion | Cardiac disorders | MedDRA |
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| Pericarditis | Cardiac disorders | MedDRA |
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| Tachycardia | Cardiac disorders | MedDRA |
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| Ventricular tachycardia | Cardiac disorders | MedDRA |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA |
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| Colitis | Gastrointestinal disorders | MedDRA |
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| Diarrhoea | Gastrointestinal disorders | MedDRA |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA |
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| Nausea | Gastrointestinal disorders | MedDRA |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA |
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| Vomiting | Gastrointestinal disorders | MedDRA |
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| Chest discomfort | General disorders | MedDRA |
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| Chest pain | General disorders | MedDRA |
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| Death | General disorders | MedDRA |
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| Implant site haematoma | General disorders | MedDRA |
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| Implant site pain | General disorders | MedDRA |
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| Lead dislodgement | General disorders | MedDRA |
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| Bacteraemia | Infections and infestations | MedDRA |
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| Bronchitis | Infections and infestations | MedDRA |
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| Cellulitis | Infections and infestations | MedDRA |
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| Encephalitis | Infections and infestations | MedDRA |
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| Implant site infection | Infections and infestations | MedDRA |
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| Osteomyelitis | Infections and infestations | MedDRA |
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| Pneumonia | Infections and infestations | MedDRA |
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| Septic shock | Infections and infestations | MedDRA |
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| Urinary tract infection | Infections and infestations | MedDRA |
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| Wound infection | Infections and infestations | MedDRA |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA |
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| Electrocardiogram ST segment elevation | Investigations | MedDRA |
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| Dehydration | Metabolism and nutrition disorders | MedDRA |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA |
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| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA |
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| Small cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA |
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| Cerebrovascular accident | Nervous system disorders | MedDRA |
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| Renal failure | Renal and urinary disorders | MedDRA |
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| Renal failure acute | Renal and urinary disorders | MedDRA |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA |
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| Hypotension | Vascular disorders | MedDRA |
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| Venous occlusion | Vascular disorders | MedDRA |
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Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evera MRI Clinical Research Specialist | Medtronic, Inc | 800-328-2518 | 62813 | medtronicCRMtrials@medtronic.com |
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