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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
266
MRI-related Complication Free Rate
Number of patients free of MRI-related complications
Time frame: MRI scan to one month later
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds
Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude
Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.
Time frame: Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Saint George Hospital
Kogarah, New South Wales, Australia
Flinders Medical Centre
Bedford Park, Australia
Landesklinikum St. Pölten
Sankt Pölten, Austria
Wilhelminenspital
Vienna, Austria
Les Cliniques du Sud Luxembourg Cliniques Saint Joseph
Arlon, Belgium
Hôpital Saint-Joseph
Gilly, Belgium
Hospital Clínico Pontificia Universidad Católica
Santiago, Chile
Prince of Wales Hospital Hong Kong
Hong Kong, China
Fundacion Cardioinfantil
Bogotá, Colombia
Klinikum Links der Weser
Bremen, Germany
...and 26 more locations
Time frame: During MRI scans (9-12 weeks post-implant)
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude
Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period