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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01110915




Registration number
NCT01110915
Ethics application status
Date submitted
23/04/2010
Date registered
27/04/2010
Date last updated
30/04/2013

Titles & IDs
Public title
Advisa MRI Clinical Study
Scientific title
Advisa MRI™ System Clinical Investigation
Secondary ID [1] 0 0
AdvisaMRI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Magnetic Resonance Imaging 0 0
Cardiac Pacemaker, Artificial 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic Advisa MRI Implantable Pulse Generator (IPG)
Treatment: Devices - Medtronic CapSureFix MRI™ active fixation MRI lead

Experimental: MRI group - 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.

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


Treatment: Devices: 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.

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Magnetic Resonance Imaging (MRI)-Related Complications
Timepoint [1] 0 0
MRI scan to one-month post-MRI scan
Primary outcome [2] 0 0
Atrial Pacing Capture Threshold Success
Timepoint [2] 0 0
Pre-MRI/waiting period to one month post-MRI/waiting period
Primary outcome [3] 0 0
Ventricular Pacing Capture Threshold Success
Timepoint [3] 0 0
Pre-MRI /waiting period to 1-month post-MRI/waiting period
Secondary outcome [1] 0 0
Atrial Sensed Amplitude Success
Timepoint [1] 0 0
Pre-MRI /waiting period to 1-month post-MRI/waiting period
Secondary outcome [2] 0 0
Ventricular Sensed Amplitude Success
Timepoint [2] 0 0
Pre-MRI /waiting period to 1-month post-MRI/waiting period
Secondary outcome [3] 0 0
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
Timepoint [3] 0 0
During MRI scans
Secondary outcome [4] 0 0
System-related Complications
Timepoint [4] 0 0
Implant to four months post implant

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
269
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Adelaide Cardiology - Adelaide
Recruitment hospital [4] 0 0
Epworth - Richmond
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
- Chermside
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Austria
State/province [12] 0 0
Sankt Pölten
Country [13] 0 0
Belgium
State/province [13] 0 0
Gilly
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
France
State/province [15] 0 0
Montpellier
Country [16] 0 0
France
State/province [16] 0 0
Rouen Cedex
Country [17] 0 0
France
State/province [17] 0 0
Saint Etienne
Country [18] 0 0
Germany
State/province [18] 0 0
Bonn
Country [19] 0 0
Germany
State/province [19] 0 0
Rostock
Country [20] 0 0
Germany
State/province [20] 0 0
Ulm
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Italy
State/province [24] 0 0
Roma
Country [25] 0 0
Netherlands
State/province [25] 0 0
Amsterdam
Country [26] 0 0
Netherlands
State/province [26] 0 0
Den Haag
Country [27] 0 0
Netherlands
State/province [27] 0 0
Nieuwegein
Country [28] 0 0
Switzerland
State/province [28] 0 0
Lausanne
Country [29] 0 0
Switzerland
State/province [29] 0 0
Zürich
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Bournemouth
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT01110915
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Advisa MRI Trial Leader
Address 0 0
Medtronic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01110915