N/A N=266 Randomized

Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment

Magnetic Resonance Imaging (MRI) · Cardiac Pacing

Bottom Line

View on ClinicalTrials.gov: NCT01755143 ↗

Enrolled (actual)

266

Serious AEs

12.8%

Results posted

Jul 2015

Primary outcome: Primary: MRI-related Complication Free Rate — 156 participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Magnetic Resonance Imaging scan sequences of the head, neck, and chest (Other); Pacemaker System (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY MRI-related Complication Free Rate	156	<0.0001 sig
PRIMARY Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds	142; 80	—
PRIMARY Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds	152; 82	<0.0001 sig
SECONDARY Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude	141; 78	<0.0001 sig
SECONDARY Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.	—	<0.0001 sig
SECONDARY Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude	134; 76	0.0004 sig

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.

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01755143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.