Advisa MRI Clinical Study

Magnetic Resonance Imaging Clinical Trial

Official title:

Advisa MRI™ System Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110915
• Other study ID #: AdvisaMRI
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: April 23, 2013
• Start date: June 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: German Institute of Medical Documentation and InformationHungary: National Institute of PharmacyIsrael: Ministry of HealthItaly: Ministry of HealthNetherlands: Ministry of Health, Welfare and SportSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationCanada: Ethics Review CommitteeAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Pacemaker, Artificial
• Magnetic Resonance Imaging

Intervention

Device:
• Medtronic Advisa MRI Implantable Pulse Generator (IPG)
Advisa MRI IPG is a dual chamber, multi-programmable IPG 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.
• Medtronic CapSureFix MRI™ active fixation MRI lead
The Medtronic CapSureFix MRI™ active fixation MRI lead is a transvenous, bipolar, silicone, steroid eluting and active fixation pacing lead. It is based on the commercially available Medtronic Model 5076 lead and has been modified for use in the MRI environment. The MRI lead is used for both atrial and ventricular applications.

Locations

Country	Name	City	State
Australia	Adelaide Cardiology	Adelaide	South Australia
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	St. George Hospital	Kogarah	New South Wales
Australia	Epworth	Richmond	Victoria
Austria	Landesklinikum St. Pölten	Sankt Pölten
Belgium	Hôpital Saint-Joseph	Gilly
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Quebec
France	CHRU Hôpital Arnaud de Villeneuve	Montpellier
France	CHU Hôpiteaux de Rouen	Rouen Cedex
France	Centre Hospitalier Universitaire Saint Étienne	Saint Etienne
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität	Rostock
Germany	Universitätsklinikum Ulm	Ulm
Hungary	Semmelweis Egyetem AOK	Budapest
Israel	Rambam Health Care Campus	Haifa
Italy	Azienda Complesso Ospedaliero San Filippo Neri	Roma
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milano
Netherlands	Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark	Amsterdam
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	HagaZiekenhuis - Locatie Leyweg	Den Haag
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	UniversitätsSpital Zürich	Zürich
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Wythenshawe Hospital	Manchester
United States	University of Virginia Health System	Charlottesville	Virginia
United States	The Lindner Research Center	Cincinnati	Ohio
United States	Baylor Heart & Vascular Hosptial	Dallas	Texas
United States	Greenville Hospital System	Greenville	South Carolina
United States	Mid America Heart Institute	Kansas City	Missouri
United States	Cardiology Associates of East Tennesee	Knoxville	Tennessee
United States	Mid Florida Cardiology	Orlando	Florida
United States	Raleigh Cardiology Associates	Raleigh	North Carolina
United States	Central Coast Cardiology	Salinas	California
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

References & Publications (2)

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; — View Citation

Schwitter J, Kanal E, Schmitt M, Anselme F, Albert T, Hayes DL, Bello D, Tóth 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 pa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Imaging (MRI)-Related Complications	For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.	MRI scan to one-month post-MRI scan	No
Primary	Atrial Pacing Capture Threshold Success	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 to one month post-MRI/waiting period	No
Primary	Ventricular Pacing Capture Threshold Success	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 to 1-month post-MRI/waiting period	No
Secondary	Atrial Sensed Amplitude Success	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 to 1-month post-MRI/waiting period	No
Secondary	Ventricular Sensed Amplitude Success	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 to 1-month post-MRI/waiting period	No
Secondary	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 AEAC.	During MRI scans	No
Secondary	System-related Complications	Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.	Implant to four months post implant	No