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Study Results
Related Studies
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace (AVAIL)
This study has been terminated.
( Slow enrollment. )
Study NCT00356057   Information provided by Biotronik, Inc.

First Received on July 21, 2006.   Last Updated on May 2, 2012   History of Changes
Results First Received: December 2, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Congestive Heart Failure
Intervention: Device: Protos DR/CLS and Stratos LV CRT pacemakers

  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
A total of 153 patients were enrolled at 22 clinical sites from December 9, 2004 (the first implant of the study) through May 12, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No patients were excluded before assigment to groups. A total of 27 patients did not receive a device implant due to withdrawal of consent, inelegibility after randomization and unability to implant the LV lead.

Reporting Groups
  Description
biV-pacing With CLS Rate Adaption (Protos CLS) Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.

Participant Flow:   Overall Study
    biV-pacing With CLS Rate Adaption (Protos CLS)     biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)     RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)  
STARTED     58     61     34  
IMPLANTED     49     52     25  
COMPLETED     45     47     22  
NOT COMPLETED     13     14     12  



  Baseline Characteristics
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Reporting Groups
  Description
biV-pacing With CLS Rate Adaption (Protos CLS) Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
biV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
RV Pacing With Accelerometer Based Rate Adaption (Stratos LV) Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.

Baseline Measures
    biV-pacing With CLS Rate Adaption (Protos CLS)     biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)     RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)     Total  
Number of Participants  
[units: participants]
 		  58     61     34     153  
Age  
[units: years]
Mean ± Standard Deviation 		  74.1  ± 8.4     72.7  ± 7.8     72.3  ± 8.2     73.1  ± 8.1  
Gender  
[units: participants]
 		       
Female     34     39     17     90  
Male     24     22     17     63  
Region of Enrollment  
[units: participants]
 		       
United States     57     59     33     149  
Canada     1     2     1     4  



  Outcome Measures

1.  Primary:   Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months   [ Time Frame: Change from baseline to six months post-procedure ]
  Show Outcome Measure 1

2.  Primary:   System-related Complication-free Rate   [ Time Frame: at six months post-procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Improvement in 6-minute Walk Test   [ Time Frame: at six months post-procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Improvement in QOL Score   [ Time Frame: at six months post-procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Cardiac Remodeling Assessments by Echocardiography   [ Time Frame: at six months post-procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Changes in NYHA Classification   [ Time Frame: at six months post-procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Rate of CHF Hospitalizations and Total Mortality   [ Time Frame: at six months post-procedure ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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 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.


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
Early termination due lack of enrollment.  


Results Point of Contact:  
Name/Title: Katerina de Metz, Director Clinical Studies
Organization: BIOTRONIK, Inc.
phone: 5036752169
e-mail: katerina.demetz@biotronik.com


No publications provided


Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00356057     History of Changes
Other Study ID Numbers: G040150
Study First Received: July 21, 2006
Results First Received: December 2, 2008
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration





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