Advisa MRI Clinical Study

NCT01110915 | Completed Results

• 1 other identifier: AdvisaMRI
• Study Type: interventional
• Target: 269
• Locations: 12 countries
• Sites: 33

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).

Conditions

Magnetic Resonance Imaging; Cardiac Pacemaker, Artificial

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (4)

• Atrial Sensed Amplitude Success

  Pre-MRI /waiting period to 1-month post-MRI/waiting period

• Ventricular Sensed Amplitude Success

  Pre-MRI /waiting period to 1-month post-MRI/waiting period

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

  During MRI scans

• System-related Complications

  Implant to four months post implant

Study Arms (2)

MRI group

EXPERIMENTAL

Subjects randomized to the MRI group will undergo a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.

Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG); Device: Medtronic CapSureFix MRI™ active fixation MRI lead

Control group

ACTIVE COMPARATOR

Subjects randomized to the Control group will wait for one hour without having any MRI scan at 9-12 weeks post-implant.

Device: Medtronic Advisa MRI Implantable Pulse Generator (IPG); Device: Medtronic CapSureFix MRI™ active fixation MRI lead

Interventions

Medtronic Advisa MRI Implantable Pulse Generator (IPG) DEVICE

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.

Also known as: Model A2DR01, Model A3DR01

Control group; MRI group

Medtronic CapSureFix MRI™ active fixation MRI lead DEVICE

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.

Also known as: Model 5086 MRI lead

Control group; MRI group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (37)

Central Coast Cardiology

Salinas, California, 93901-3901, United States

Location

Mid Florida Cardiology

Orlando, Florida, 32806-2014, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Raleigh Cardiology Associates

Raleigh, North Carolina, 27610, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219-2906, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Cardiology Associates of East Tennesee

Knoxville, Tennessee, 37923-4310, United States

Location

Baylor Heart & Vascular Hosptial

Dallas, Texas, 75226-1300, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908-0816, United States

Location

St. George Hospital

Kogarah, New South Wales, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, Australia

Location

Adelaide Cardiology

Adelaide, South Australia, Australia

Location

Epworth

Richmond, Victoria, Australia

Location

Landesklinikum St. Pölten

Sankt Pölten, Austria

Location

Hôpital Saint-Joseph

Gilly, Belgium

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

CHRU Hôpital Arnaud de Villeneuve

Montpellier, France

Location

CHU Hôpiteaux de Rouen

Rouen, France

Location

Centre Hospitalier Universitaire Saint Étienne

Saint-Etienne, France

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität

Rostock, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Semmelweis Egyetem AOK

Budapest, Hungary

Location

Rambam Health Care Campus

Haifa, Israel

Location

IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

Location

Azienda Complesso Ospedaliero San Filippo Neri

Roma, Italy

Location

Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark

Amsterdam, Netherlands

Location

VU Medisch Centrum

Amsterdam, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

HagaZiekenhuis - Locatie Leyweg

The Hague, Netherlands

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

UniversitätsSpital Zürich

Zurich, Switzerland

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Wythenshawe Hospital

Manchester, United Kingdom

Location

Related 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;10(5):685-91. doi: 10.1016/j.hrthm.2013.01.022. Epub 2013 Jan 17.

  PMID: 23333721 RESULT

• 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.

  PMID: 23434621 RESULT

Results Point of Contact

• Title: Advisa MRI Clinical Research Specialist
• Organization: Medtronic, Inc

medtronicCRMtrials@medtronic.com

800-328-2518

Study Officials

• Advisa MRI Trial Leader

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2013
• Last Updated: April 30, 2013
• Results First Posted: April 4, 2013

Record last verified: 2013-04

Locations

HU (1); NL (4); AU (1); IT (2); CA (2); GB (2); DE (3); BE (1); CH (2); IL (1); FR (3); US (11)