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Completed

NCT Number: NCT01755143

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

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.

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Key information

Conditions

Magnetic Resonance Imaging (MRI) Cardiac Pacing

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint George Hospital, Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Magnetic Resonance Imaging scan sequences of the head, neck, and chest

Other

Pacemaker System

Device

Other names: Model 5076 Lead, Advisa MRI Pacemaker

Primary outcomes

  1. MRI-related Complication Free Rate

    Time frame: MRI scan to one month later

    Number of patients free of MRI-related complications

  2. 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

    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.

  3. 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

    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 outcomes

  1. 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

    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.

  2. Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.

    Time frame: During MRI scans (9-12 weeks post-implant)

    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

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

CapSureFix® Novus Model 5076 Lead MRI Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2012
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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