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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01576016
Registration number
NCT01576016
Ethics application status
Date submitted
4/04/2012
Date registered
12/04/2012
Date last updated
10/11/2020
Titles & IDs
Public title
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
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Scientific title
Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
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Secondary ID [1]
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60028820
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adverse Effect of MRI on an Implanted Pacemaker Lead
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Adverse Effect of MRI on an Implanted Pacemaker
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Accent MRI system (lead safety)
Treatment: Devices - Accent MRI system (with MRI scan)
Experimental: Lead Safety - Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead
Experimental: Accent MRI system MRI Scan Group - Patient implanted with an Accent MRI system will receive an MRI scan to evaluate safety and efficacy of the Accent MRI system in an MRI environment
Treatment: Devices: Accent MRI system (lead safety)
Patients implanted with an Accent MRI system
Treatment: Devices: Accent MRI system (with MRI scan)
Patients implanted with an Accent MRI system will receive an MRI scan
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period
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Assessment method [1]
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Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit
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Timepoint [1]
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Implant through 2 months
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Primary outcome [2]
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Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period
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Assessment method [2]
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Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit
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Timepoint [2]
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Implant through 2 months
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Primary outcome [3]
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Freedom From RA Related Complications in the Chronic Period
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Assessment method [3]
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Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
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Timepoint [3]
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2 months through 12 months
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Primary outcome [4]
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Freedom From Right Ventricular Lead Related Complications in the Chronic Period
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Assessment method [4]
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Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit
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Timepoint [4]
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2 months through 12 months
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Primary outcome [5]
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Freedom From MRI Scan-related Complications
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Assessment method [5]
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Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit
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Timepoint [5]
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MRI Scan visit through 1 month after MRI scan visit
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Primary outcome [6]
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Change in Atrial Capture Threshold From Pre to Post MRI Scan
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Assessment method [6]
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Percentage of patients with an increase in RA capture thresholds of <= 0.5 V, at a pulse width of 0.5 ms .
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Timepoint [6]
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MRI Scan visit to 1 month after MRI scan visit
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Primary outcome [7]
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Change in Ventricular Capture Threshold Pre to Post MRI Scan
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Assessment method [7]
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Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms.
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Timepoint [7]
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MRI Scan visit to 1 month after MRI scan visit
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Primary outcome [8]
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Change in Atrial Sense Amplitude
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Assessment method [8]
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Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV.
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Timepoint [8]
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MRI Scan visit to 1 month after MRI scan visit
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Primary outcome [9]
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Change in Ventricular Sense Amplitude
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Assessment method [9]
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Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV.
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Timepoint [9]
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MRI Scan visit to 1 month after the MRI Scan visit
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Secondary outcome [1]
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Freedom From System-related Complications
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Assessment method [1]
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Percentage of patients who do not have system-related complications from implant through the 12 month study visit
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Timepoint [1]
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Implant through 12 months
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Secondary outcome [2]
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Atrial Capture Threshold at the MRI Visit
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Assessment method [2]
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Percentage of patients with RA capture threshold =2.0 volts (V) at the MRI visit
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Timepoint [2]
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MRI Scan visit (approx 3 months post implant)
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Secondary outcome [3]
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Ventricular Capture Threshold at the MRI Visit
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Assessment method [3]
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Percentage of patients with RV capture threshold =2.0 V at the MRI visit
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Timepoint [3]
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MRI Scan visit (approx 3 months post implant)
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Eligibility
Key inclusion criteria
Eligible patients will meet all of the following:
1. Have an approved indication per American College of Cardiology (ACC)/American Heart
Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a
pacemaker
2. Will receive a new pacemaker and lead
3. Be willing to undergo an elective MRI scan without sedation
4. Be able to provide informed consent for study participation (legal guardian is NOT
acceptable)
5. Be willing and able to comply with the prescribed follow-up tests and schedule of
evaluations
6. Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients will be excluded if they meet any of the following:
1. Are medically indicated for an MRI scan at the time of enrollment
2. Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new
pacemaker and lead is required for enrollment
3. Have an existing active/inactive implanted medical device, e.g., neurostimulator,
infusion pump, etc.
4. Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm
clip, non-MRI compatible devices or material, metals or alloys, etc.)
5. Have a lead extender or adaptor
6. Be unable to fit in MRI bore; will come into contact with the magnet façade inside the
MRI bore.
7. Have a prosthetic tricuspid heart valve
8. Are currently participating in a clinical investigation that includes an active
treatment arm
9. Are allergic to dexamethasone sodium phosphate (DSP)
10. Are pregnant or planning to become pregnant during the duration of the study
11. Have a life expectancy of less than 12 months due to any condition
12. Patients with exclusion criteria required by local law (e.g., age)
13. Are unable to comply with the follow up schedule
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/03/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/02/2018
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Sample size
Target
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Accrual to date
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Final
950
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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St. Andrews Hospital - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Illinois
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Kentucky
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Louisiana
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Missouri
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Nebraska
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New York
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North Carolina
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South Carolina
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Texas
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Virginia
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Wisconsin
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Belgium
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Finland
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East Finland
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Netherlands
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Utrecht
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety
and efficacy of the Accent MRI™ System in a patient population indicated for implant of a
pacemaker within and outside of the MRI environment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01576016
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Grant Kim
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Address
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Abbott Medical Devices
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01576016
Download to PDF