N/A
Completed N=464
EMRI SureScan™ Clinical Study
Bradycardia · Slow Heart Beat
Source: ClinicalTrials.gov NCT00433654 ↗
Enrolled (actual)
464
Serious AEs
40.5%
Results posted
Aug 2011
Primary outcomePrimary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.001
Summary
The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Magnetic Resonance Imaging (MRI)-Related Complications |
— | <0.001 sig |
| PRIMARY Atrial Pacing Capture Threshold Success |
165; 164 | — |
| PRIMARY Ventricular Pacing Capture Threshold Success |
190; 183 | <0.001 sig |
| PRIMARY Atrial Sensed Amplitude Success |
124; 129 | <0.001 sig |
| PRIMARY Ventricular Sensed Amplitude Success |
130; 129 | <0.001 sig |
| SECONDARY Subjects With System-related Complications |
37 | <0.001 sig |
| SECONDARY System Related Adverse Device Effects Due to Labeling Instructions |
— | — |
| SECONDARY Occurrence of Arrhythmias |
— | — |
| SECONDARY Atrial Lead Impedance Change |
-0.6; 7.3 | — |
| SECONDARY Ventricular Lead Impedance Change |
-9.0; -5.7 | — |
| SECONDARY Atrial Lead Handling Rating |
0.53 | — |
| SECONDARY Ventricular Lead Handling Rating |
0.58 | — |
| SECONDARY Atrial Pacing Capture Threshold |
0.78; 0.77 | — |
| SECONDARY Ventricular Pacing Capture Threshold |
0.82; 0.90 | — |
| SECONDARY Atrial Sensed Amplitude |
3.0; 3.1 | — |
| SECONDARY Ventricular Sensed Amplitude |
10.1; 10.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
- Subject available for follow-up at study center for length of study.
- Subject able and willing to undergo elective MRI scanning without sedation.
Exclusion Criteria
- Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
- Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
- Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
- Subject with exclusion criteria required by local law.
- Subject who intends to participate in another clinical study during this clinical study.
Data sourced from ClinicalTrials.gov (NCT00433654). 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. Informational only — not medical advice.