EMRI SureScan™ Clinical Study

EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

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.