Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Conditions
Brief summary
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.
Interventions
Bradycardia Slow Heart Beat
MRI scan of head and lower back.
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 18 years * Subject body height greater than 140 cm (4' 7) * Able and willing to complete MRI testing * Able to provide written informed consent * Available for follow-up visit at the study site * Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.) * Pacemaker implanted pectorally * All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment * Underling rhythm identifiable during sensing test * All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms * Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms * Pacing impedance is between 200 and 1500 ohm * Able and willing to use the Cardio Messenger 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 4.8V @ 1.0 ms * \|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline\| ≤ 0.5 V * All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms * The pacemaker system has been implanted for at least 6 weeks. * Subject did not have a pacemaker or lead explant, exchange or reposition in the previous 6 weeks. * All lead impedances are between 200 and 1500 ohm. * Battery status is at least 30% of capacity
Exclusion criteria
* Enrolled in any other clinical study * For pacemaker systems that include an atrial lead, subjects with either * Persistent atrial arrhythmia (lasting longer than 7 days or requiring cardioversion) * Permanent atrial arrhythmia * Life expectancy of less than three months * Pregnancy * Cardiac surgery expected in the next three months * Implanted with other medical devices that may interact with MRI, such as: * abandoned pacemaker/ICD leads * lead extensions * mechanical valves * other active medical devices * non-MRI compatible devices * other metallic artifacts/components in body that may interact with MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate | 1 Month Post-MRI | — |
| Percentage of Participants Free of Atrial Pacing Threshold Rise | Pre-MRI, 1 Month Post-MRI | Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up. |
| Percentage of Participants Free of Ventricular Pacing Threshold Rise | Pre-MRI, 1 Month Post-MRI | Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up. |
| Percentage of Participants Free of P-wave Sensing Attenuation | Pre-MRI, 1 Month Post-MRI | Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up. |
| Percentage of Participants Free of R-wave Sensing Attenuation | Pre-MRI, 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 |
|---|---|
| Pacemaker Therapy Patients with a ProMRI Pacemaker System
Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back. | 229 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Pacemaker Therapy |
|---|---|
| Age, Continuous | 71.2 years STANDARD_DEVIATION 10.7 |
| Gender Female | 71 Participants |
| Gender Male | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 229 |
| serious Total, serious adverse events | 21 / 229 |
Outcome results
Primary
MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate
Time frame: 1 Month Post-MRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacemaker Therapy | MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate | 100 percentage of participants |
Primary
Percentage of Participants Free of Atrial Pacing Threshold Rise
Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.
Time frame: Pre-MRI, 1 Month Post-MRI
Population: Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacemaker Therapy | Percentage of Participants Free of Atrial Pacing Threshold Rise | 99.0 percentage of participants |
Primary
Percentage of Participants Free of P-wave Sensing Attenuation
Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Time frame: Pre-MRI, 1 Month Post-MRI
Population: Number of participants with an atrial lead and same atrial sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacemaker Therapy | Percentage of Participants Free of P-wave Sensing Attenuation | 99.4 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: Pre-MRI, 1 Month Post-MRI
Population: Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacemaker Therapy | Percentage of Participants Free of R-wave Sensing Attenuation | 99.5 percentage of participants |
Primary
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Time frame: Pre-MRI, 1 Month Post-MRI
Population: Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacemaker Therapy | Percentage of Participants Free of Ventricular Pacing Threshold Rise | 100 percentage of participants |