Text Size

PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00146848
First received: September 2, 2005
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
Results First Received: February 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices

  Participant Flow
  Show Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
DDD-40 Atrial Tracking (atrial rate support above 40 bpm)
DDD-70 Atrial Rate Support (atrial rate support above 70 bpm)
DDDR-40 Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
Total Total of all reporting groups

Baseline Measures
    DDD-40     DDD-70     DDDR-40     Total  
Number of Participants  
[units: participants]
 		  475     488     470     1433  
Age  
[units: years]
Mean ± Standard Deviation 		  67.3  ± 11.4     67.5  ± 10.4     66.7  ± 11.6     67.2  ± 11.1  
Gender  
[units: participants]
 		       
Female     165     156     165     486  
Male     310     332     305     947  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Composite Score   [ Time Frame: From randomization (6-weeks) through 12-month visit ]
  Show Outcome Measure 1

2.  Secondary:   Change in Quality of Life   [ Time Frame: From randomization (6-weeks) through 12-month visit ]
  Show Outcome Measure 2

3.  Secondary:   Change in Self Assessed Physical Activity   [ Time Frame: From randomization (6-weeks) through 12-month visit ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide 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 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
Lack of longer-term follow-up. Single blind design where investigator could be aware of treatment assignment. Two conservative atrial support pacing modes; results should not be extended to substantially more atrial pacing and higher heart rates.  


Results Point of Contact:  
Name/Title: Kira Stolen
Organization: Clinical Affairs
phone: 1 800 CARDIAC
e-mail: cshd@bsci.com


Publications:

Publications automatically indexed to this study:


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00146848     History of Changes
Other Study ID Numbers: CR-CA-100604-H, PEGASUS
Study First Received: September 2, 2005
Results First Received: February 28, 2010
Last Updated: December 20, 2011
Health Authority: United States: Institutional Review Board