Clinical trial NCT01755143: Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment
Official title: CapSureFix® Novus Model 5076 Lead MRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging (MRI)
Cardiac Pacing
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 266
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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).

Primary outcomes:
measure: MRI-related Complication Free Rate
timeFrame: MRI scan to one month later
measure: Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
timeFrame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
measure: Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds
timeFrame: 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
timeFrame: Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period
measure: Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
timeFrame: During MRI scans (9-12 weeks post-implant)
measure: Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude
timeFrame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: Saint George Hospital
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Sankt Pölten
country: Austria
facility: Landesklinikum St. Pölten
city: Wien
country: Austria
facility: Wilhelminenspital
city: Arlon
country: Belgium
facility: Les Cliniques du Sud Luxembourg Cliniques Saint Joseph
city: Gilly
country: Belgium
facility: Hôpital Saint-Joseph
city: Santiago
country: Chile
facility: Hospital Clínico Pontificia Universidad Católica
city: Hong Kong
country: China
facility: Prince of Wales Hospital Hong Kong
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefässe
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Gurgaon
country: India
facility: Medanta The Medicity
state: Haryana
city: Bangalore
country: India
facility: Sri Jayadeva Institute of Cardiovascular Sciences and Research
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research
city: Jaipur
country: India
facility: Fortis Escorts Hospital
city: Mumbai
country: India
facility: Holy Family Hospital
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Punjab
country: India
facility: Dayanand Medical College
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis - Locatie Leyweg
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis - Locatie Nieuwegein
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Center
city: Belgrade
country: Serbia
facility: Klinicki Centar Srbije
city: Sremska Kamenica
country: Serbia
facility: Institut za Kardiovaskularne Bolesti Vojvodine
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Bratislava
country: Slovakia
facility: Narodny ustav srdcovych a cievnych chorob
city: Pretoria
country: South Africa
facility: Netcare Unitas Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari Clínic de Barcelona
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital cantonal
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: