N/A
N=263
Advisa MRI Clinical Study
Magnetic Resonance Imaging · Cardiac Pacemaker, Artificial
Bottom Line
View on ClinicalTrials.gov: NCT01110915 ↗Enrolled (actual)
263
Serious AEs
25.1%
Results posted
Apr 2013
Primary outcome: Primary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medtronic Advisa MRI Implantable Pulse Generator (IPG) (Device); Medtronic CapSureFix MRI™ active fixation MRI lead (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Magnetic Resonance Imaging (MRI)-Related Complications |
— | <0.0001 sig |
| PRIMARY Atrial Pacing Capture Threshold Success |
141; 75 | — |
| PRIMARY Ventricular Pacing Capture Threshold Success |
146; 78 | <0.0001 sig |
| SECONDARY Atrial Sensed Amplitude Success |
134; 72 | 0.0010 sig |
| SECONDARY Ventricular Sensed Amplitude Success |
138; 74 | 0.0001 sig |
| SECONDARY Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans. |
— | <0.0001 sig |
| SECONDARY System-related Complications |
20 | <0.05 sig |
Summary
The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).
Eligibility Criteria
Inclusion Criteria
- Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines
- Subjects who are able to undergo a pectoral implant
- Subjects who are able and willing to undergo elective magnetic resonance (MR) scanning without sedation
- Subjects who are geographically stable and available for follow-up at the study center 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 1.0 milligram (mg) dexamethasone acetate may be contraindicated
- Subjects who require a legally authorized representative to obtain consent
- Subjects who have a previously implanted pacemaker or implantable cardioverter defibrillator (ICD) (abandoned pacemaker and/or defibrillator leads are not permitted; however subjects with complete system explants are not excluded)
- Subjects who are immediate candidates for an ICD
- Subjects who require an indicated MR scan, other than those specifically described in the study, before the 4 months follow-up
- Subjects with previously implanted active medical devices
- 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 exclusion criteria required by local law (e.g. age, breastfeeding)
Data sourced from ClinicalTrials.gov (NCT01110915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.