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Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications (OPTI-MIND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00976482
First received: September 11, 2009
Last updated: December 5, 2016
Last verified: December 2016
Results First Received: March 15, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Bradyarrhythmia

  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
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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
Pacemaker Patients currently implanted with permanent Pacemaker according to guidelines

Participant Flow:   Overall Study
    Pacemaker
STARTED   1745 
Eligible for Last Follow up   1487 
COMPLETED   1486 
NOT COMPLETED   259 
Death                208 
Withdrawal by Subject                45 
Center terminated                1 
Protocol Violation                5 



  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.
among the 1745 initial patients 5 were excluded for inclusion criteria violations (deviations from correct signature of informed consent)

Reporting Groups
  Description
Pacemaker Patients currently implanted with permanent Pacemaker according to guidelines

Baseline Measures
   Pacemaker 
Overall Participants Analyzed 
[Units: Participants]
 1740 
Age 
[Units: Years]
Mean (Standard Deviation)
 76  (10) 
Gender 
[Units: Participants]
Count of Participants
 
Female      1047  60.2% 
Male      693  39.8% 
Primary Indication for Permanent Pacing 
[Units: Participants]
 
sinus node dysfunction   565 
Atrioventricular Block   840 
Neuro-mediated   61 
Permanent AF with Slow Ventr. Response   274 


  Outcome Measures

1.  Primary:   Two-year All-cause Mortality   [ Time Frame: 2 years ]


  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 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: dr Mauro Biffi
Organization: ospedale S Orsola- Malpighi, Bologna, Italy
phone: +393337661449
e-mail: mauro.biffi@aosp.bo.it



Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00976482     History of Changes
Other Study ID Numbers: 07-09
Study First Received: September 11, 2009
Results First Received: March 15, 2015
Last Updated: December 5, 2016