Bradycardia
Conditions
Keywords
Bradycardia, MRI Conditional Pacemaker, St Jude Medical, Accent MRI Pacemaker, Tendril MRI Lead
Brief summary
The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.
Detailed description
Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group. Clinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.
Interventions
DIAGNOSTIC_TESTNon-Diagnostic Cardiac MRI scan
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants are assigned to one of two groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker * Will receive a new dual chamber pacemaker and leads * Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan * Be able to provide informed consent for study participation * Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations * Is not contraindicated for an MRI scan (per the pre-MRI safety screening form) * Age≥18 years * Subjects must be able to undergo pectoral implantation
Exclusion criteria
* Having an existing pacemaker or Implantable Cardioverter Defibrillator (ICD) .A new pacemaker and lead is required for enrollment * Permanent Atrial Fibrillation/Flutter * Are medically indicated for an MRI scan at the time of enrollment * Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc * Have a non-MRI compatible device or material implanted * Have a lead extender or adaptor * Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore * Are currently participating in a clinical investigation that includes an active treatment arm * Are allergic to dexamethasone sodium phosphate(DSP) * Are pregnant or planning to become pregnant during the duration of the study * Have a life expectancy of less than 12 months due to any condition * Subjects with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From MRI Scan-related Complications | MRI Visit ,1 Month Post MRI Visit | Number of subjects who were free from MRI scan-related complications |
| Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan | MRI Visit ,1 Month Post MRI Visit | Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit |
| Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan | MRI Visit, 1 Month Post MRI Visit | Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit |
| Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan | MRI Visit, 1 Month Post MRI Visit | Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit |
| Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan | MRI Visit, 1 Month Post MRI Visit | Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit |
Countries
China, Hong Kong, India, Malaysia, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac MRI Scan Group Non-diagnostic cardiac MRI scan | 140 |
| Control Group No non-diagnostic cardiac MRI scan | 143 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cardiac Resynchronization Therapy | 1 | 0 |
| Overall Study | Death | 4 | 0 |
| Overall Study | Lost to Follow-up | 1 | 6 |
| Overall Study | Patient not confirmed as MRI compatible | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Cardiac MRI Scan Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 11.2 | 69.4 years STANDARD_DEVIATION 11.6 | 67.4 years STANDARD_DEVIATION 11.7 |
| Arrhythmia History Atrial Fibrillation | 29 Participants | 55 Participants | 26 Participants |
| Arrhythmia History Atrial Flutter | 7 Participants | 13 Participants | 6 Participants |
| Arrhythmia History Monomorphic Ventricular Tachycardia | 1 Participants | 1 Participants | 0 Participants |
| Arrhythmia History Premature Ventricular | 1 Participants | 3 Participants | 2 Participants |
| Arrhythmia History Supraventricular Tachycardia | 1 Participants | 1 Participants | 0 Participants |
| Cardiomyopathy History Ischemic Cardiomyopathy | 2 Participants | 5 Participants | 3 Participants |
| Cardiomyopathy History Non-ischemic Cardiomyopathy | 1 Participants | 1 Participants | 0 Participants |
| Cardiovascular Medication Aldosterone Inhibitors | 0 Participants | 2 Participants | 2 Participants |
| Cardiovascular Medication Angiotensin Converting Enzyme Inhibitor | 18 Participants | 35 Participants | 17 Participants |
| Cardiovascular Medication Angiotensin II Receptor Blockers | 31 Participants | 62 Participants | 31 Participants |
| Cardiovascular Medication Antiarrhythmics (Class I) | 3 Participants | 4 Participants | 1 Participants |
| Cardiovascular Medication Antiarrhythmics (Class II) | 2 Participants | 9 Participants | 7 Participants |
| Cardiovascular Medication Anticoagulants | 15 Participants | 28 Participants | 13 Participants |
| Cardiovascular Medication Antiplatelets | 47 Participants | 95 Participants | 48 Participants |
| Cardiovascular Medication Beta-Blockers | 31 Participants | 50 Participants | 19 Participants |
| Cardiovascular Medication Calcium Channel Blockers | 54 Participants | 94 Participants | 40 Participants |
| Cardiovascular Medication Cardiac Glycosides (Digitalis) | 2 Participants | 3 Participants | 1 Participants |
| Cardiovascular Medication Diuretics | 16 Participants | 32 Participants | 16 Participants |
| Cardiovascular Medication Nitrates | 16 Participants | 25 Participants | 9 Participants |
| Cardiovascular Medication Other Medication | 38 Participants | 67 Participants | 29 Participants |
| Region of Enrollment China | 3 Participants | 7 Participants | 4 Participants |
| Region of Enrollment Hong Kong | 15 Participants | 30 Participants | 15 Participants |
| Region of Enrollment India | 54 Participants | 109 Participants | 55 Participants |
| Region of Enrollment Malaysia | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment Singapore | 20 Participants | 40 Participants | 20 Participants |
| Region of Enrollment Thailand | 46 Participants | 92 Participants | 46 Participants |
| Sex: Female, Male Female | 58 Participants | 119 Participants | 61 Participants |
| Sex: Female, Male Male | 82 Participants | 164 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 140 | 0 / 143 |
| other Total, other adverse events | 1 / 140 | 1 / 143 |
| serious Total, serious adverse events | 6 / 140 | 6 / 143 |
Outcome results
Primary
Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Time frame: MRI Visit, 1 Month Post MRI Visit
Population: Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV \&1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac MRI Scan Group | Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan | 105 Participants |
| Control Group | Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan | 111 Participants |
Comparison: The hypothesis was:H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visitp-value: 0.044690% CI: [-9.8, 4.3]Farrington-Manning test
Primary
Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan
Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit
Time frame: MRI Visit ,1 Month Post MRI Visit
Population: Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV \&1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac MRI Scan Group | Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan | 110 Participants |
| Control Group | Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan | 117 Participants |
Comparison: The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL\>-10%~* PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visitp-value: 0.000790% CI: [-5.6, 3.8]Farrington-Manning Test
Primary
Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan
Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit
Time frame: MRI Visit, 1 Month Post MRI Visit
Population: Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV \&1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac MRI Scan Group | Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan | 118 Participants |
| Control Group | Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan | 124 Participants |
Comparison: The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visitp-value: 0.001290% CI: [-6.2, 2.8]Farrington-Manning test
Primary
Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Time frame: MRI Visit, 1 Month Post MRI Visit
Population: Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV \&1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac MRI Scan Group | Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan | 102 Participants |
| Control Group | Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan | 106 Participants |
Comparison: The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visitp-value: 0.000290% CI: [-3.2, 8.4]Farrington-Manning test
Primary
Freedom From MRI Scan-related Complications
Number of subjects who were free from MRI scan-related complications
Time frame: MRI Visit ,1 Month Post MRI Visit
Population: All subjects in Cardiac MRI Scan group who underwent an elective non-diagnostic cardiac MRI scan and completed all protocol specific visits were included in the analysis. Subjects who withdrew from the study before 1 month post MRI visit and had no MRI scan related complications were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac MRI Scan Group | Freedom From MRI Scan-related Complications | 123 Participants |
Comparison: The hypothesis was: H0: P≤ 90% vs H1: P\>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan groupp-value: <0.0190% CI: [97.6, 100]Clopper-Pearson