EMRI SureScan™ Clinical Study
EMRI SureScan™ Clinical Study
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).
This study is a prospective, multi-center global study.
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.