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Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response (CLEAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00355797
First received: July 21, 2006
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
Results First Received: June 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Bradycardia
Interventions: Device: Closed Loop Stimulation (CLS)
Device: Standard Rate Adaptive (R) Technology
Device: Non-rate adaptive (DDD) pacing

  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
CLS Rate Adaptive Pacing Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
Standard Rate Adaptive Pacing Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
No Rate Adaptive Pacing Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.

Participant Flow:   Overall Study
    CLS Rate Adaptive Pacing     Standard Rate Adaptive Pacing     No Rate Adaptive Pacing  
STARTED     741     369     381  
COMPLETED     501     221     239  
NOT COMPLETED     240     148     142  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Performance of Activities of Daily Living Tests (6-minute Walk and Sweep)   [ Time Frame: within 45 days of enrollment ]
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2.  Primary:   Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test)   [ Time Frame: within 45 days of enrollment ]
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3.  Secondary:   Change in Quality of Life   [ Time Frame: baseline and 12 months ]
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4.  Secondary:   Mode Reprogramming   [ Time Frame: 12 months ]
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5.  Secondary:   Atrial Fibrillation (AF) Burden   [ Time Frame: 12 months ]
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6.  Secondary:   Cardiac Symptoms   [ Time Frame: 12 months ]
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7.  Secondary:   Change in New York Heart Association (NYHA) Class   [ Time Frame: baseline and 12 months ]
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8.  Secondary:   Change in 6-minute Walk Test Distance   [ Time Frame: baseline and 12 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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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Results Point of Contact:  
Name/Title: CLEAR Study CSE
Organization: BIOTRONIK, Inc.
phone: 503-451-8051


No publications provided


Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00355797     History of Changes
Other Study ID Numbers: 20060536
Study First Received: July 21, 2006
Results First Received: June 6, 2011
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board