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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01576016




Registration number
NCT01576016
Ethics application status
Date submitted
4/04/2012
Date registered
12/04/2012
Date last updated
1/11/2017

Titles & IDs
Public title
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
Scientific title
Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
Secondary ID [1] 0 0
60028820
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adverse Effect of MRI on an Implanted Pacemaker Lead 0 0
Adverse Effect of MRI on an Implanted Pacemaker 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Accent MRI system
Treatment: Devices - Accent MRI system

Active Comparator: Accent MRI system MRI Scan Group - Patient implanted with an Accent MRI system will receive an MRI scan

Placebo Comparator: Accent MRI System MRI Control Group - Patient implanted with an Accent MRI system will not receive an MRI scan


Treatment: Devices: Accent MRI system
Patients implanted with an Accent MRI system will receive 30 minutes of magnetic scan imaging

Treatment: Devices: Accent MRI system
Patients implanted with an Accent MRI system will wait for one hour without receiving an MRI scan

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

Outcomes
Primary outcome [1] 0 0
Freedom from right atrial (RA) lead-related complications in the acute period - Proportion of patients who do not have RA lead-related complications from implant through the 2 month study visit
Timepoint [1] 0 0
Implant through 2 months
Primary outcome [2] 0 0
Freedom from right ventricular (RV) lead-related complications in the acute time period - Proportion of patients who do not have RV lead-related complications from implant through the 2 month study visit
Timepoint [2] 0 0
Implant through 2 months
Primary outcome [3] 0 0
Freedom from RA related complications in the chronic period - Proportion of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit
Timepoint [3] 0 0
2 months thru 12 months
Primary outcome [4] 0 0
Freedom from right ventricular lead related complications in the chronic period - Proportion of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit
Timepoint [4] 0 0
2 months thru 12 months
Primary outcome [5] 0 0
Freedom from MRI scan-related complications - Proportion of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit
Timepoint [5] 0 0
MRI Scan visit and 1 month after MRI scan visit
Primary outcome [6] 0 0
Change in atrial capture thresholds (before and after the MRI Scan) - Difference in the proportion of patients with an increase in RA capture thresholds at 0.5 ms between those randomized to receive an MRI scan versus those not receiving an MRI scan.
Timepoint [6] 0 0
MRI Scan visit and 1 month after MRI scan visit
Primary outcome [7] 0 0
Change in ventricular capture thresholds (before and after the MRI scan) - Difference in the proportion of patients with an increase in RV capture thresholds at 0.5 ms between those randomized to receive an MRI scan versus those not receiving an MRI scan.
Timepoint [7] 0 0
MRI Scan visit and 1 month after MRI scan visit
Primary outcome [8] 0 0
Change in atrial sensing threshold (before and after the MRI scan) - Difference in the proportion of patients with an increase in RA sensing threshold between those randomized to receive an MRI scan versus those not receiving an MRI scan.
Timepoint [8] 0 0
MRI Scan visit and 1 month after MRI scan visit
Primary outcome [9] 0 0
Change in ventricular sensing threshold (before and after the MRI scan) - Difference in the proportion of patients with an increase in RV sensing threshold between those randomized to receive an MRI scan versus those not receiving an MRI scan.
Timepoint [9] 0 0
MRI Scan visit and 1 month after the MRI Scan visit
Secondary outcome [1] 0 0
Freedom from system-related complications - Proportion of patients who do not have system-related complications from implant through the 12 month study visit
Timepoint [1] 0 0
Implant through 12 months
Secondary outcome [2] 0 0
Atrial capture threshold at the MRI visit - Proportion of patients with RA capture threshold =2.0 volts (V) at the MRI visit
Timepoint [2] 0 0
MRI Scan visit (approx 3 months post implant)
Secondary outcome [3] 0 0
Ventricular capture threshold at the MRI visit - Proportion of patients with RV capture threshold =2.0 V at the MRI visit
Timepoint [3] 0 0
MRI Scan visit (approx 3 months post implant)

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)
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
St. Andrews Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
State/province [4] 0 0
California
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United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Michigan
Country [12] 0 0
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State/province [12] 0 0
Minnesota
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State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
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New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
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State/province [18] 0 0
Oklahoma
Country [19] 0 0
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Pennsylvania
Country [20] 0 0
United States of America
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South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Belgium
State/province [25] 0 0
B Cap R
Country [26] 0 0
Finland
State/province [26] 0 0
East Finland
Country [27] 0 0
Netherlands
State/province [27] 0 0
Utrecht

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01576016
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Grant Kim
Address 0 0
Abbott Medical Devices
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/show/NCT01576016