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Model 20105 Lead Study

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ClinicalTrials.gov Identifier: NCT02301429
Recruitment Status : Terminated (Low implant success rate(46%). For the successfull implants, 3month FU and available electrical data showed an increase in threshold values for the left atrium)
First Posted : November 25, 2014
Results First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sick Sinus Node Syndrome
Intervention: Device: Model 20105

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Model 20105

Receiving the model 20105 Lead

Model 20105: implant and follow-up of study device


Participant Flow:   Overall Study
    Model 20105
STARTED   16 
COMPLETED   13 
NOT COMPLETED   3 
not acceptable vascular anatomy                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
Model 20105

Receiving the model 20105 Lead

Model 20105: implant and follow-up of study device


Baseline Measures
   Model 20105 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.2  (11.2) 
Gender 
[Units: Participants]
 
Female   8 
Male   8 
QRS duration 
[Units: Msec]
Mean (Standard Deviation)
 108.7  (17.6) 


  Outcome Measures

1.  Primary:   All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.   [ Time Frame: 1 month ]


  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
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  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Study manager
Organization: Medtronic Regional Clinical Center
phone: 0039(0)22 241371
e-mail: laura.manotta@medtronic.com



Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT02301429     History of Changes
Other Study ID Numbers: LV DDD
First Submitted: October 20, 2014
First Posted: November 25, 2014
Results First Submitted: September 2, 2016
Results First Posted: October 26, 2016
Last Update Posted: October 26, 2016