Cardiac Pacing, Magnetic Resonance Imaging (MRI)
Conditions
Brief summary
The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.
Interventions
OTHERMagnetic Resonance Imaging scan sequences of the head, neck, and chest
DEVICEPacemaker System
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines * Subjects who are able to undergo a pectoral implant * Subjects who: * are receiving an IPG for the first time, OR * are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads * 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
Exclusion criteria
* Subjects with a mechanical tricuspid heart valve. * Subjects with a history of significant tricuspid valvular disease. * Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated. * Subjects who require a legally authorized representative to obtain consent. * Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads * Subjects who are immediate candidates for an ICD. * Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up. * Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG). * Subjects with a non-MRI compatible device (such as ICDs or 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 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 this clinical study. * Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control. * Subjects with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI-related Complication Free Rate | MRI scan to one month later | Number of patients free of MRI-related complications |
| Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds | Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period | Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits. |
| Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds | Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period | Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude | Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period | Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits. |
| Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans. | During MRI scans (9-12 weeks post-implant) | The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee |
| Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude | Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period | Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits. |
Countries
Australia, Austria, Belgium, Chile, China, Colombia, Germany, Hong Kong, India, Netherlands, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI Group Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Pacemaker System | 177 |
| Control Group Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
Pacemaker System | 89 |
| Total | 266 |
Baseline characteristics
| Characteristic | Control Group | Total | MRI Group |
|---|---|---|---|
| Age, Continuous | 67.8 Years STANDARD_DEVIATION 15.1 | 69.2 Years STANDARD_DEVIATION 12.2 | 70.0 Years STANDARD_DEVIATION 10.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 78 Participants | 52 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 16 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 40 Participants | 26 Participants |
| Race (NIH/OMB) White | 45 Participants | 132 Participants | 87 Participants |
| Sex: Female, Male Female | 40 Participants | 108 Participants | 68 Participants |
| Sex: Female, Male Male | 49 Participants | 158 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 177 | 0 / 89 |
| serious Total, serious adverse events | 28 / 177 | 6 / 89 |
Outcome results
Primary
MRI-related Complication Free Rate
Number of patients free of MRI-related complications
Time frame: MRI scan to one month later
Population: Patients who underwent an MRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | MRI-related Complication Free Rate | 156 participants |
Comparison: Null Hypothesis: MRI-related complication-free rate between the MRI scan and one-month post-MRI \<90%.p-value: <0.0001exact test of binomial proportions
Primary
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
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 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds | 142 participants |
| Control Group | Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds | 80 participants |
Comparison: Null hypothesis: % successes MRI group ≤ % successes Control group -10%.Farrington-Manning test
Primary
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds
Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds | 152 participants |
| Control Group | Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds | 82 participants |
Comparison: Null hypothesis: % successes MRI group ≤ % successes Control group -10%.p-value: <0.000195% CI: [-5.4, 4.1]Farrington-Manning test
Secondary
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee
Time frame: During MRI scans (9-12 weeks post-implant)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans. | 0 participants |
Comparison: Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.p-value: <0.0001exact test of binomial proportions
Secondary
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude
Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.
Time frame: Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period
Population: Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude | 141 participants |
| Control Group | Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude | 78 participants |
Comparison: Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.p-value: <0.0001Farrington-Manning test
Secondary
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude
Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRI Group | Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude | 134 participants |
| Control Group | Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude | 76 participants |
Comparison: Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.p-value: 0.0004Farrington-Manning test