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EMRI SureScan™ Clinical Study

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00433654
First received: February 2, 2007
Last updated: October 17, 2011
Last verified: July 2011
History of Changes
Results First Received: January 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Bradycardia
Slow Heart Beat
Interventions: Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)
Other: Magnetic Resonance Imaging (MRI) scan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first implant occurred 5 February 2007. A total of 484 subjects were enrolled, including 113 enrollments at 13 centers in the US and 371 enrollments at 29 centers outside of the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Implant procedure included EnRhythm MRI SureScan pacemaker and 2 CapsureFix MRI 5086MRI leads. Pacemaker function and adverse events were assessed. 17 subjects did not have an implant attempt. 3 subjects received a subset of the 3 system components and were followed for safety. All other subjects were randomized after successful implant.

Reporting Groups
  Description
MRI Group The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
Control Group The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant

Participant Flow:   Overall Study
    MRI Group     Control Group  
STARTED     258     206  
COMPLETED     243 [1]   201 [1]
NOT COMPLETED     15     5  
Death                 4                 0  
Missed visit                 6                 3  
Subject not yet due for visit                 4                 0  
Withdrawal by Subject                 1                 2  
[1] Subjects completing the 4-month follow-up.



  Baseline Characteristics
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Reporting Groups
  Description
MRI Group The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
Control Group The control group waited for one hour (did not have an MRI scan) at 9-12 weeks post-implant.
Total Total of all reporting groups

Baseline Measures
    MRI Group     Control Group     Total  
Number of Participants  
[units: participants]
 		  258     206     464  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     75     67     142  
>=65 years     183     139     322  
Age  
[units: years]
Mean ± Standard Deviation 		  69.3  ± 12.9     68.0  ± 12.6     68.7  ± 12.8  
Gender  
[units: participants]
 		     
Female     104     71     175  
Male     154     135     289  
Region of Enrollment  
[units: participants]
 		     
United States     66     33     99  
Europe     157     141     298  
Canada     34     32     66  
Middle East     1     0     1  



  Outcome Measures
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1.  Primary:   Magnetic Resonance Imaging (MRI)-Related Complications   [ Time Frame: MRI scan to one-month post-MRI scan ]
  Show Outcome Measure 1

2.  Primary:   Atrial Pacing Capture Threshold Success   [ Time Frame: 9-12 week visit to 4-month visit ]
  Show Outcome Measure 2

3.  Primary:   Ventricular Pacing Capture Threshold Success   [ Time Frame: 9-12 week visit to 4-month visit ]
  Show Outcome Measure 3

4.  Primary:   Atrial Sensed Amplitude Success   [ Time Frame: 9-12 week visit to 4-month visit ]
  Hide Outcome Measure 4

Measure Type Primary
Measure Title Atrial Sensed Amplitude Success
Measure Description Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).
Time Frame 9-12 week visit to 4-month visit  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects were excluded from this analysis if: they did not have atrial sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week atrial sensed amplitude was less than 1.5 mV.

Reporting Groups
  Description
MRI Group The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
Control Group The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.

Measured Values
    MRI Group     Control Group  
Number of Participants Analyzed  
[units: participants]
 		  131     139  
Atrial Sensed Amplitude Success  
[units: participants]
 		  124     129  


Statistical Analysis 1 for Atrial Sensed Amplitude Success
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Farrington-Manning
P Value [4] <0.001
Difference in percentages [5] 1.9
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis: success rate MRI group <= success rate control group - 10%
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin is 10%.
[3] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



5.  Primary:   Ventricular Sensed Amplitude Success   [ Time Frame: 9-12 week visit to 4-month visit ]
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6.  Secondary:   Subjects With System-related Complications   [ Time Frame: Implant to 4 Months ]
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7.  Secondary:   System Related Adverse Device Effects Due to Labeling Instructions   [ Time Frame: Implant through 18 months post-implant ]
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8.  Secondary:   Occurrence of Arrhythmias   [ Time Frame: During the MRI scan ]
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9.  Secondary:   Atrial Lead Impedance Change   [ Time Frame: 9-12 week visit and 4-month visit ]
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10.  Secondary:   Ventricular Lead Impedance Change   [ Time Frame: 9-12 week visit and 4-month visit ]
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11.  Secondary:   Atrial Lead Handling Rating   [ Time Frame: During implant ]
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12.  Secondary:   Ventricular Lead Handling Rating   [ Time Frame: During implant ]
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13.  Secondary:   Atrial Pacing Capture Threshold   [ Time Frame: 3 or 4 months post-implant ]
  Show Outcome Measure 13

14.  Secondary:   Ventricular Pacing Capture Threshold   [ Time Frame: 3 or 4 months post-implant ]
  Show Outcome Measure 14

15.  Secondary:   Atrial Sensed Amplitude   [ Time Frame: 3 or 4 months post-implant ]
  Show Outcome Measure 15

16.  Secondary:   Ventricular Sensed Amplitude   [ Time Frame: 3 or 4 months post-implant ]
  Show Outcome Measure 16


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Comparisons with a historical control (5076 Lead) were performed for secondary objectives #11-#16, however the results database is currently only designed to allow for reporting of participants specifically enrolled as part of this protocol.  


Results Point of Contact:  
Name/Title: EnRhythm MRI Clinical Research Specialist
Organization: Medtronic, Inc
phone: 800-328-2518 ext 62813
e-mail: medtronicCRMtrials@medtronic.com


No publications provided


Responsible Party: EMRI Clinical Research Specialist, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00433654     History of Changes
Other Study ID Numbers: 212
Study First Received: February 2, 2007
Results First Received: January 11, 2011
Last Updated: October 17, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Austria: Federal bureau for security in public health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Germany: Bezirksregierung Dusseldorf
Italy: Ministry of Health
Netherlands: Federal Ministry of Social Affairs, public health and Environment Service Medical Aids
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)