At a glance
ClinicalIndex Comparison RecordN/ACompleted· 266 enrolled
Drug / intervention
Magnetic Resonance Imaging scan sequences of the head, neck, and chest +1 moreother
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.
CapSureFix® Novus Model 5076 Lead MRI Study
In Brief
A clinical study evaluating Magnetic Resonance Imaging scan sequences of the head, neck, and chest and Pacemaker System for Magnetic Resonance Imaging (MRI) and Cardiac Pacing. Completed, enrolled 266 participants across 36 sites in 19 countries.
Detailed Summary
The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMagnetic Resonance Imaging (MRI), Cardiac Pacing
CountriesAustralia, Austria, Belgium, Chile, China, Colombia, Germany, Hong Kong, India, Netherlands, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
First PostedDec 2012
Primary CompletionOct 2013
TodayJul 2026
First PostedDec 24, 2012
Enrollment StartDec 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.5 years ago
Interventions
Magnetic Resonance Imaging scan sequences of the head, neck, and chestother
Pacemaker Systemdevice