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Trial record 1 of 1 for:    01781078
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ImageReady(TM) MR Conditional Pacing System Clinical Study (SAMURAI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01781078
First received: January 25, 2013
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Bradycardia
Sinus Node Dysfunction
Interventions: Radiation: MRI
Device: ImageReady System implant

  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
363 patients were consented and enrolled in this study. 11 patients were withdrawn pre-implantation. 352 patients underwent the implantation procedure and 348 patients were successfully implanted. 1 patient died prior to randomization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MRI Group

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

ImageReady System implant: Pacemaker and lead(s) implant

Control Group

Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.

ImageReady System implant: Pacemaker and lead(s) implant

Patients Withdrawn Prior to Randomization Patients who consented to the study but were withdrawn prior to the randomization.

Participant Flow:   Overall Study
    MRI Group   Control Group   Patients Withdrawn Prior to Randomization
STARTED   229 [1]   118 [1]   16 
COMPLETED   217 [2]   113 [2]   0 
NOT COMPLETED   12   5   16 
[1] Randomized post implantation
[2] Patients having completed the MRI + 1 month (Primary endpoint assessment)



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
MRI Group

Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment

ImageReady System implant: Pacemaker and lead(s) implant

Control Group

Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.

ImageReady System implant: Pacemaker and lead(s) implant

Total Total of all reporting groups

Baseline Measures
   MRI Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 229   118   347 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.0  (13.0)   70.4  (11.9)   69.4  (12.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      102  44.5%      63  53.4%      165  47.6% 
Male      127  55.5%      55  46.6%      182  52.4% 
Region of Enrollment 
[Units: Participants]
     
Canada   6   2   8 
Singapore   12   8   21 
United States   162   83   254 
China   7   3   10 
Malaysia   21   8   32 
Israel   21   13   36 
Australia   0   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Participants Without MR Scan-related Complications   [ Time Frame: MRI Visit + 1 Month ]

2.  Primary:   Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit   [ Time Frame: MRI + 1 Month Visit ]

3.  Primary:   Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit   [ Time Frame: MRI + 1 Month Visit ]

4.  Secondary:   Proportion of Participants Without ImageReady System-related Complications   [ Time Frame: 3 months post implant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Caroline Beaudoint
Organization: Boston Scientific
phone: +32479904163
e-mail: Caroline.Beaudoint@bsci.com



Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01781078     History of Changes
Other Study ID Numbers: BSC-CDM00047737
Study First Received: January 25, 2013
Results First Received: April 7, 2017
Last Updated: April 7, 2017