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

CapSureFix® Novus Model 5076 Lead MRI Study

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 Overview

• Status: Completed
• Conditions: Cardiac Pacing; Magnetic Resonance Imaging (MRI)
• Intervention / Treatment: Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest; Device: Pacemaker System

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia, 5042
    • Flinders Medical Centre
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Saint George Hospital
• Austria
  • Sankt Pölten, Austria, 3100
    • Landesklinikum St. Pölten
  • Wien, Austria, 1160
    • Wilhelminenspital
• Belgium
  • Arlon, Belgium, 6700
    • Les Cliniques du Sud Luxembourg Cliniques Saint Joseph
  • Gilly, Belgium, 6060
    • Hôpital Saint-Joseph
• Chile
  • Santiago, Chile, 8320000
    • Hospital Clinico Pontificia Universidad Catolica
• China
  • Hong Kong, China
    • Prince of Wales Hospital Hong Kong
• Colombia
  • Bogota, Colombia, 102973
    • Fundacion Cardioinfantil
• Germany
  • Bremen, Germany, 28277
    • Klinikum Links der Weser
  • Dresden, Germany, 01099
    • Praxisklinik Herz und Gefäße
  • Jena, Germany, 07747
    • Universitatsklinikum Jena
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
• India
  • Bangalore, India
    • Sri Jayadeva Institute of Cardiovascular Sciences and Research
  • Chandigarh, India, 160012
    • Post Graduate Institute of Medical Education & Research
  • Jaipur, India, 302017
    • Fortis Escorts Hospital
  • Mumbai, India, 400050
    • Holy Family Hospital
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences
  • Punjab, India, 141001
    • Dayanand Medical College
  • Haryana
    • Gurgaon, Haryana, India, 122041
      • Medanta the Medicity
• Netherlands
  • Den Haag, Netherlands, 2545
    • HagaZiekenhuis - Locatie Leyweg
  • Nieuwegein, Netherlands, 3435
    • St. Antonius Ziekenhuis - Locatie Nieuwegein
  • Rotterdam, Netherlands, 3078
    • Maasstad ziekenhuis
• Portugal
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Prince Sultan Cardiac Center
• Serbia
  • Belgrade, Serbia, 11000
    • Klinicki Centar Srbije
  • Sremska Kamenica, Serbia, 21204
    • Institut Za Kardiovaskularne Bolesti Vojvodine
• Singapore
  • Singapore, Singapore, 168752
    • National Heart Centre Singapore
• Slovakia
  • Bratislava, Slovakia, 83348
    • Narodny ustav srdcovych a cievnych chorob
• South Africa
  • Pretoria, South Africa, 0140
    • Netcare Unitas Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Universitari Clínic de Barcelona
• Switzerland
  • Fribourg, Switzerland, 1708
    • HFR Fribourg - Hôpital Cantonal
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois
• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI-related Complication Free Rate	Number of patients free of MRI-related complications	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.	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.	Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 24, 2012

Study Record Updates

• Last Update Posted (Estimate): July 20, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 5076 MRI