At a glance
ClinicalIndex Comparison RecordN/ACompleted· 484 enrolled
Drug / intervention
Implantable Pulse Generator (IPG) and Pacing Leads (wires) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation
In Brief
A clinical study evaluating Implantable Pulse Generator (IPG) and Pacing Leads (wires) and Magnetic Resonance Imaging (MRI) scan for Bradycardia and Slow Heart Beat. Completed, enrolled 484 participants across 45 sites in 11 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBradycardia, Slow Heart Beat
CountriesAustria, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Switzerland, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedFeb 2007
Primary CompletionNov 2008
Study CompletionAug 2010
TodayJul 2026
First PostedFeb 12, 2007
Enrollment StartFeb 1, 2007
Primary CompletionNov 1, 2008
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.4 years ago
Interventions
Implantable Pulse Generator (IPG) and Pacing Leads (wires)device
Pacer and leads
Magnetic Resonance Imaging (MRI) scanother
One hour MRI scan on the head and lower back.