Bradycardia
Conditions
Brief summary
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population includes patients with a standard bradycardia pacing indication.
Detailed description
Magnetic resonance imaging (MRI) is a diagnostic method to view high quality two and three dimensional images of the body. However, magnetic resonance imaging systems generate three electromagnetic fields that are used to produce an image. These include a static magnetic field, a time varying gradient magnetic field, and a radiofrequency field. All three of these fields interact with implanted devices and could create hazards for the device, the patient, or both. Due to these issues, currently marketed pacemaker systems may be contraindicated for use in an MRI environment. St. Jude Medical has developed a system, the Accent MRI™ system, comprised of the Accent MRI™ device and the Tendril MRI™ lead, and an investigational MRI Activator™, designed to mitigate such interactions.
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker * Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices). * Is ≥ 18 years of age. * Able to provide written informed consent prior to any investigational related procedure. * Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion criteria
* Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment). * Have an existing active implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, etc.). * Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.). * Have a lead extender, plug or adaptor. * Have a prosthetic tricuspid heart valve. * Are currently participating in another investigational device or drug investigation. * 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 from Screening due to any life-threatening condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From RA and RV Lead-related Complications | up to 12 months post-implant | Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Accent MRI System Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads | 466 |
| Total | 466 |
Baseline characteristics
| Characteristic | Accent MRI System |
|---|---|
| Age, Continuous | 71.74 years STANDARD_DEVIATION 11.71 |
| AtrioVentricular-Block (AV-Block) 1st Degree AV Block | 41 participants |
| AtrioVentricular-Block (AV-Block) 2nd Degree AV Block | 99 participants |
| AtrioVentricular-Block (AV-Block) 3rd Degree AV block | 147 participants |
| AtrioVentricular-Block (AV-Block) No AV Block | 179 participants |
| Neurocardiogenic Syncope No Previous Neurocardiogenic Syncope | 391 participants |
| Neurocardiogenic Syncope Previous Neurocardiogenic Syncope | 75 participants |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 272 Participants |
| Sick Node Dysfunction No Sick Node Dysfunction | 261 participants |
| Sick Node Dysfunction Sick Node Dysfunction | 205 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 78 / 466 |
| serious Total, serious adverse events | 174 / 466 |
Outcome results
Primary
Freedom From RA and RV Lead-related Complications
Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.
Time frame: up to 12 months post-implant
Population: A total of 464 patients were implanted. 463 patients (99.78%) were implanted with Accent MRI™ systems with the Tendril MRI™ leads while the remaining 1 patient (0.22%) was implanted with a device that was not an Accent MRI™ system. This patient was excluded from all primary endpoint analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Accent MRI System | Freedom From RA and RV Lead-related Complications | Acute Timeframe (Implant to 2 Months) | 97.19 percentage of participants |
| Accent MRI System | Freedom From RA and RV Lead-related Complications | Chronic Timeframe (>2 Months to 12 Months) | 99.14 percentage of participants |