Clinical trial NCT01110915: Advisa MRI Clinical Study
Official title: Advisa MRI™ System Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Cardiac Pacemaker, Artificial
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 269
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

Detailed description: The Advisa MRI IPG is a dual chamber, multi-programmable IPG. The IPG is indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.

Subjects will have required follow-up visits after implant, at 2 months, 9-12 weeks, 3 months, 4 months, 6 months and every 6 months thereafter until the study ends. The MR scans will occur at the 9-12 weeks visit.

Eligibility criteria: Inclusion Criteria:

* Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to the American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines
* Subjects who are able to undergo a pectoral implant
* Subjects who are able and willing to undergo elective magnetic resonance (MR) scanning without sedation
* Subjects who are geographically stable and available for follow-up at the study center 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 1.0 milligram (mg) dexamethasone acetate may be contraindicated
* Subjects who require a legally authorized representative to obtain consent
* Subjects who have a previously implanted pacemaker or implantable cardioverter defibrillator (ICD) (abandoned pacemaker and/or defibrillator leads are not permitted; however subjects with complete system explants are not excluded)
* Subjects who are immediate candidates for an ICD
* Subjects who require an indicated MR scan, other than those specifically described in the study, before the 4 months follow-up
* Subjects with previously implanted active medical devices
* 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: Magnetic Resonance Imaging (MRI)-Related Complications
timeFrame: MRI scan to one-month post-MRI scan
measure: Atrial Pacing Capture Threshold Success
timeFrame: Pre-MRI/waiting period to one month post-MRI/waiting period
measure: Ventricular Pacing Capture Threshold Success
timeFrame: Pre-MRI /waiting period to 1-month post-MRI/waiting period
Secondary outcomes:
measure: Atrial Sensed Amplitude Success
timeFrame: Pre-MRI /waiting period to 1-month post-MRI/waiting period
measure: Ventricular Sensed Amplitude Success
timeFrame: Pre-MRI /waiting period to 1-month post-MRI/waiting period
measure: Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
timeFrame: During MRI scans
measure: System-related Complications
timeFrame: Implant to four months post implant
Other outcomes:
Locations:
city: Salinas
country: United States
facility: Central Coast Cardiology
state: California
city: Orlando
country: United States
facility: Mid Florida Cardiology
state: Florida
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: Mid America Heart Institute
state: Missouri
city: Raleigh
country: United States
facility: Raleigh Cardiology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Knoxville
country: United States
facility: Cardiology Associates of East Tennesee
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hosptial
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Kogarah
country: Australia
facility: St. George Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Adelaide Cardiology
state: South Australia
city: Richmond
country: Australia
facility: Epworth
state: Victoria
city: Sankt Pölten
country: Austria
facility: Landesklinikum St. Pölten
city: Gilly
country: Belgium
facility: Hôpital Saint-Joseph
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
city: Montpellier
country: France
facility: CHRU Hôpital Arnaud de Villeneuve
city: Rouen Cedex
country: France
facility: CHU Hôpiteaux de Rouen
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire Saint Étienne
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
city: Roma
country: Italy
facility: Azienda Complesso Ospedaliero San Filippo Neri
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis - Locatie Leyweg
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
Study officials:
affiliation: Medtronic
name: Advisa MRI Trial Leader
role: STUDY_CHAIR
References:
citation: Gimbel JR, Bello D, Schmitt M, Merkely B, Schwitter J, Hayes DL, Sommer T, Schloss EJ, Chang Y, Willey S, Kanal E; Advisa MRI System Study Investigators. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013 May;10(5):685-91. doi: 10.1016/j.hrthm.2013.01.022. Epub 2013 Jan 17.
citation: Schwitter J, Kanal E, Schmitt M, Anselme F, Albert T, Hayes DL, Bello D, Toth A, Chang Y, van Osch D, Sommer T; Advisa MRI System Study Investigators. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Heart Rhythm. 2013 Jun;10(6):864-72. doi: 10.1016/j.hrthm.2013.02.019. Epub 2013 Feb 19.