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ACC - Atrial Contribution to CRT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180323
First received: September 12, 2005
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
Results First Received: March 9, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dilated Cardiomyopathy
Intervention: Device: Renewal

  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
Group 1 No text entered.

Participant Flow:   Overall Study
    Group 1  
STARTED     43  
COMPLETED     43  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
 		  43  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     15  
Age  
[units: years]
Mean ± Standard Deviation 		  61  ± 11  
Gender  
[units: participants]
 		 
Female     12  
Male     31  
Region of Enrollment  
[units: participants]
 		 
Denmark     43  



  Outcome Measures
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1.  Primary:   Aortic Velocity Time Integral (VTI)   [ Time Frame: At implant (baseline), 3 months and 6 months Follow-up ]
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2.  Primary:   Optimal AV-Delay (AVD)   [ Time Frame: Implant (baseline), 3 months and 6 months Follow-up ]
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3.  Secondary:   6 Minute Walk Test   [ Time Frame: implant (baseline), 3 months and 6 months Follow-up ]
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4.  Secondary:   Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: implant (baseline), 3 Months, 6 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 NOT 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.


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: Dr. Jesper Hastrup Svendsen
Organization: Rigshospitalet, Copenhagen Unviversity Hospital, Denmark
e-mail: jesper.hastrup.svendsen@rh.regionh.dk


No publications provided


Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00180323     History of Changes
Other Study ID Numbers: ACC Version 1.1 11/09/2003
Study First Received: September 12, 2005
Results First Received: March 9, 2012
Last Updated: October 11, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics