Status:
COMPLETED
EMRI SureScan™ Clinical Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Bradycardia
Slow Heart Beat
Eligibility:
All Genders
Phase:
NA
Brief 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 ...
Detailed Description
This study is a prospective, multi-center global study.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
484 Patients enrolled
Trial Details
Trial ID
NCT00433654
Start Date
February 1 2007
End Date
August 1 2010
Last Update
September 15 2025
Active Locations (45)
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1
Redwood City, California, United States
2
Salinas, California, United States
3
Orlando, Florida, United States
4
Peachtree City, Georgia, United States