N/A
N=283
Accent Cardiac MRI Study
Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT02041702 ↗Enrolled (actual)
283
Serious AEs
4.2%
Results posted
Aug 2019
Primary outcome: Primary: Freedom From MRI Scan-related Complications — 123 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-Diagnostic Cardiac MRI scan (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From MRI Scan-related Complications |
123 | <0.01 sig |
| PRIMARY Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan |
110; 117 | 0.0007 sig |
| PRIMARY Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan |
118; 124 | 0.0012 sig |
| PRIMARY Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan |
105; 111 | 0.0446 sig |
| PRIMARY Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan |
102; 106 | 0.0002 sig |
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.
Eligibility Criteria
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 exclusion criteria required by local law (e.g. age)
- Are unable to comply with the follow up schedule
Data sourced from ClinicalTrials.gov (NCT02041702). 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.