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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01755143
First received: December 18, 2012
Last updated: June 22, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Magnetic Resonance Imaging (MRI)
Cardiac Pacing
Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Device: Pacemaker System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: CapSureFix® Novus Model 5076 Lead MRI Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • MRI-related Complication Free Rate [ Time Frame: MRI scan to one month later ] [ Designated as safety issue: No ]
    Number of patients free of MRI-related complications

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans. [ Time Frame: During MRI scans (9-12 weeks post-implant) ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 266
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI Group
Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest Device: Pacemaker System
Other Names:
  • Model 5076 Lead
  • Advisa MRI Pacemaker
Sham Comparator: Control Group
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.
Device: Pacemaker System
Other Names:
  • Model 5076 Lead
  • Advisa MRI Pacemaker

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755143

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Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01755143     History of Changes
Other Study ID Numbers: 5076 MRI
Study First Received: December 18, 2012
Results First Received: June 22, 2015
Last Updated: June 22, 2015
Health Authority: All geographies: Human Research Ethics Committee/Institutional Review Board
Australia: Therapeutic Goods Administration
Colombia: INVIMA
Taiwan: Department of Health

ClinicalTrials.gov processed this record on September 03, 2015