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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00976482
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : December 2, 2016
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Bradyarrhythmia

  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
Pacemaker Patients currently implanted with permanent Pacemaker according to guidelines

Participant Flow:   Overall Study
STARTED   1745 
Eligible for Last Follow up   1487 
Death                208 
Withdrawal by Subject                45 
Center terminated                1 
Protocol Violation                5 

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

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 76  (10) 
[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

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: dr Mauro Biffi
Organization: ospedale S Orsola- Malpighi, Bologna, Italy
phone: +393337661449

Responsible Party: Boston Scientific Corporation Identifier: NCT00976482     History of Changes
Other Study ID Numbers: 07-09
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: March 15, 2015
Results First Posted: December 2, 2016
Last Update Posted: February 1, 2017