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Trial record 1 of 1 for:    NCT01761162
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ProMRI Study of the Entovis Pacemaker System

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ClinicalTrials.gov Identifier: NCT01761162
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : November 4, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Interventions: Device: Patients with a ProMRI Pacemaker System
Other: Magnetic Resonance Imaging (MRI) scan

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Pacemaker Therapy

Patients with a ProMRI Pacemaker System

Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat

Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.


Participant Flow:   Overall Study
    Pacemaker Therapy
STARTED   229 
COMPLETED   226 
NOT COMPLETED   3 
Withdrawal by Subject                3 



  Baseline Characteristics

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
Pacemaker Therapy

Patients with a ProMRI Pacemaker System

Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat

Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.


Baseline Measures
   Pacemaker Therapy 
Overall Participants Analyzed 
[Units: Participants]
 229 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.2  (10.7) 
Gender 
[Units: Participants]
Count of Participants
 
Female      71  31.0% 
Male      158  69.0% 


  Outcome Measures

1.  Primary:   MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate   [ Time Frame: 1 Month Post-MRI ]

2.  Primary:   Percentage of Participants Free of Atrial Pacing Threshold Rise   [ Time Frame: Pre-MRI, 1 Month Post-MRI ]

3.  Primary:   Percentage of Participants Free of Ventricular Pacing Threshold Rise   [ Time Frame: Pre-MRI, 1 Month Post-MRI ]

4.  Primary:   Percentage of Participants Free of P-wave Sensing Attenuation   [ Time Frame: Pre-MRI, 1 Month Post-MRI ]

5.  Primary:   Percentage of Participants Free of R-wave Sensing Attenuation   [ Time Frame: Pre-MRI, 1 Month Post-MRI ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: Clinical Studies Engineer
Organization: Biotronik, Inc.
phone: 503-927-7230
e-mail: justin.michalski@biotronik.com


Publications of Results:

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01761162     History of Changes
Other Study ID Numbers: G120226
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: October 28, 2014
Results First Posted: November 4, 2014
Last Update Posted: February 9, 2017