Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging
Conditions
Brief summary
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
Interventions
DEVICEPatients with a ProMRI ICD System
Tachycardia Fast Heart Beat
MRI scan of heart/chest or thoracic spine
Sponsors
Biotronik, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure: * Age greater than or equal to 18 years * Able and willing to complete MRI testing * Able to provide written informed consent * Available for follow-up visit at the study site * Implanted with an ICD System consisting only of an Iforia DR-T and Linoxsmart S 65 / Linoxsmart SD 65/18 with Setrox S 53 atrial lead or Iforia VR-T DX and Linoxsmart S DX 65/15 or Linoxsmart S DX 65/17. * ICD implanted pectorally * All ICD system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment * Underlying rhythm identifiable during sensing test * All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX) * Ventricular sensing is measurable and \>6.5mV * Absence of phrenic nerve stimulation at 5.0V and 1.0 ms * Pacing impedance is between 200 and 1500 ohm * Shock Impedance is between 30 and 90 ohm * Able and willing to use the CardioMessenger II At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan: * Absence of phrenic nerve stimulation at 5.0V @ 1.0 ms * \|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline\| ≤ 0.5 V (ICD Lead Only) * All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX.) * Ventricular sensing is measurable and \>6.5mV * The ICD system has been implanted for at least six weeks. * Subject did not have an ICD or lead explant, exchange or reposition in the previous 6 weeks. * All lead pacing impedances are between 200 and 1500 ohm * Shock impedance is between 30 and 90 ohm * Battery status is at least 30% of capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate | 1 Month Post-MRI | — |
| Percentage of Participants Free of Ventricular Pacing Threshold Rise | Between Pre-MRI and 1 Month Post-MRI | Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up. |
| Percentage of Participants Free of R-wave Sensing Attenuation | Between Pre-MRI and 1 Month Post-MRI | Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ICD System Therapy Patients with a ProMRI ICD System
Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine | 154 |
| Total | 154 |
Baseline characteristics
| Characteristic | ICD System Therapy |
|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 154 |
| serious Total, serious adverse events | 23 / 154 |
Outcome results
Primary
MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate
Time frame: 1 Month Post-MRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD System Therapy | MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate | 100 percentage of participants |
Primary
Percentage of Participants Free of R-wave Sensing Attenuation
Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.
Time frame: Between Pre-MRI and 1 Month Post-MRI
Population: All participants who had measurable R-waves at both pre-MRI and and 1 Month Post-MRI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD System Therapy | Percentage of Participants Free of R-wave Sensing Attenuation | 99.3 percentage of participants |
Primary
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Time frame: Between Pre-MRI and 1 Month Post-MRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD System Therapy | Percentage of Participants Free of Ventricular Pacing Threshold Rise | 100 percentage of participants |