Overview

This trial is active, not recruiting.

Conditions magnetic resonance imaging (mri), cardiac pacing
Treatments magnetic resonance imaging scan sequences of the head, neck, and chest, pacemaker system
Sponsor Medtronic Cardiac Rhythm Disease Management
Start date December 2012
End date April 2014
Trial size 270 participants
Trial identifier NCT01755143, 5076 MRI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
magnetic resonance imaging scan sequences of the head, neck, and chest
pacemaker system Model 5076 Lead
(Sham Comparator)
Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.
pacemaker system Model 5076 Lead

Primary Outcomes

Measure
MRI-related complication free rate
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
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
time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Secondary Outcomes

Measure
Proportion of subjects who experience a decrease less than or equal to 50% in atrial sensing amplitude
time frame: Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period
Percentage of subjects free of sustained ventricular arrhythmias and asystole
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
time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines - Subjects who are able to undergo a pectoral implant - Subjects who: - are receiving an IPG for the first time, OR - are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads - Subjects who are able and willing to undergo elective MRI scanning without sedation - Subjects who are geographically stable and available for follow-up at the study site for the length of the study Exclusion Criteria: - Subjects with a mechanical tricuspid heart valve. - Subjects with a history of significant tricuspid valvular disease. - Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated. - Subjects who require a legally authorized representative to obtain consent. - Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads - Subjects who are immediate candidates for an ICD. - Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up. - Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG). - Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys). - Subjects with medical conditions that preclude the testing required by the protocol or limit study participation. - Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study. - Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control. - Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).

Additional Information

Official title CapSureFix® Novus Model 5076 Lead MRI Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.