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P3: Pacemaker Patient Profiling Study

This study has been terminated.
(Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.)
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00294060
First received: February 16, 2006
Last updated: April 6, 2011
Last verified: April 2011
Results First Received: July 1, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Bradycardia

  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
Patients were enrolled in the study from March 2004 through April 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only patients who received an approved study device were enrolled in the registry.

Reporting Groups
  Description
Pacing Patients Patients implanted with a pacemaker.

Participant Flow:   Overall Study
    Pacing Patients  
STARTED     2013  
COMPLETED     840  
NOT COMPLETED     1173  
Death                 225  
Unknown                 59  
Lost to Follow-up                 55  
Withdrawal by Subject                 11  
Physician Decision                 797  
Medical condition                 3  
Device explanted/not replaced                 23  



  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
Pacing Patients Patients implanted with a pacemaker.

Baseline Measures
    Pacing Patients  
Number of Participants  
[units: participants]
  2013  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     266  
>=65 years     1747  
Age  
[units: years]
Mean ± Standard Deviation
  76.3  ± 11.2  
Gender  
[units: participants]
 
Female     996  
Male     1017  
Region of Enrollment  
[units: participants]
 
United States     2013  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Dual Chamber Devices   [ Time Frame: at original implant ]

2.  Primary:   Days Hospitalized   [ Time Frame: implant to one year ]

3.  Primary:   Multiple In-clinic Visits   [ Time Frame: implant to one year ]


  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
Characterization of objectives also encompassed 8 device features (Capture Management, MVP, APP, ARS, PMOP, Rate Response, Mode Switch, Sinus Preference) and 10 additional clinical outcomes. More information is available through the point of contact.


  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: P3 Study Team
Organization: Medtronic CRDM
phone: 800-328-2518
e-mail: medtroniccrmtrials@medtronic.com


No publications provided


Responsible Party: P3 Study Team, Medtronic CRDM
ClinicalTrials.gov Identifier: NCT00294060     History of Changes
Other Study ID Numbers: 244
Study First Received: February 16, 2006
Results First Received: July 1, 2009
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board