Implantable Defibrillator
Conditions
Keywords
Magnetic Resonance Imaging (MRI)
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).
Interventions
DEVICEMRI scan sequences of the head and chest regions
Non-diagnostic MRI scans
OTHERWaiting Period Visit
Waiting period time will equate to 1 hour
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
Countries
Belgium, Canada, Chile, Germany, Hong Kong, Hungary, India, Italy, Netherlands, Saudi Arabia, Sweden, Switzerland, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 175 |
| 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 | 88 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 2 |
| Overall Study | Withdrawal by Subject | 10 | 4 |
Baseline characteristics
| Characteristic | MRI Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 13.5 | 60.1 years STANDARD_DEVIATION 14.3 | 60.4 years STANDARD_DEVIATION 13.8 |
| Sex: Female, Male Female | 40 Participants | 22 Participants | 62 Participants |
| Sex: Female, Male Male | 135 Participants | 66 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 175 | 0 / 88 |
| serious Total, serious adverse events | 35 / 175 | 15 / 88 |
Outcome results
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.
Time frame: MRI procedure to 1-month post-MRI
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | MRI-related Events | 147 Participants free of MRI-related events |
Comparison: The alternative hypothesis is that the MRI-related event-free rate between the MRI procedure and one month post-MRI is greater than 90%. The null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is greater than 90% or, equivalently, if the p-value is less than 0.025. Assuming type I error rate 0.025, even-free rate under null hypothesis 90% and true even-free rate 0.995, the minimum required sample size is 54 MRI scanned subjects in order to obtain 90% power.p-value: <0.0001one-proportion binomial exact test
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.
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Ventricular Pacing Capture Threshold (VPCT) | 154 Successful participants |
| Control Group | Ventricular Pacing Capture Threshold (VPCT) | 80 Successful participants |
Comparison: The percentage of subjects who experience a VPCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%p-value: <0.0001Farrington-Manning non-inferiority test
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.
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Population: Only subjects with measured ventricular sensing amplitude values both pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Ventricular Sensing Amplitude (R-wave) | 152 Successful participants |
| Control Group | Ventricular Sensing Amplitude (R-wave) | 81 Successful participants |
Comparison: The percentage of subjects who do not experience a significant decrease in ventricular sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 8%.~H0: % successes MRI group ≤ % successes Control group - 8% HA: % successes MRI group \> % successes Control group - 8%p-value: 0.0001Farrington-Manning non-inferiority test
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.
Time frame: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Atrial Pacing Capture Threshold (APCT) | 74 Successful participants |
| Control Group | Atrial Pacing Capture Threshold (APCT) | 32 Successful participants |
Comparison: The percentage of subjects who experience an APCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%p-value: 0.006Farrington-Manning non-inferiority test
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.
Time frame: MRI/waiting visit to 1-month post-MRI/Waiting visit
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Atrial Sensing Amplitude | 74 Successful participants |
| Control Group | Atrial Sensing Amplitude | 33 Successful participants |
Comparison: The percentage of subjects who do not experience a 50% decrease in atrial sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%p-value: 0.005Farrington-Manning non-inferiority test
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
Time frame: 1-month post-MRI/Waiting Period visit
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | RV Defibrillation Impedance | 145 Successful participants |
| Control Group | RV Defibrillation Impedance | 80 Successful participants |
Comparison: The percentage of subjects who have a defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms.p-value: <0.00001Farrington-Manning non-inferiority test
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
Time frame: 1-month post-MRI/Waiting Period visit
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Superior Vena Cava (SVC) Defibrillation Impedance | 42 Successful participants |
| Control Group | Superior Vena Cava (SVC) Defibrillation Impedance | 25 Successful participants |
Comparison: The percentage of subjects who have a SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose SVC defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms.Farrington-Manning non-inferiority test
Secondary
System-related Complications
Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.
Time frame: Implant to 4 months post-implant
Population: All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | System-related Complications | 254 Successful participants |
Comparison: The system-related complication-free rate between the implant procedure and the one month post-MRI/waiting period is greater than 80%.~H0: p ≤ 0.80 HA: p \> 0.80 where p is the system-related complication-free rate between the implant procedure and 120 days (the approximate time of the one month post-MRI/waiting period visit).p-value: <0.0001Kaplan-Meier method