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ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy (ADVANCE_D)

This study has been completed.
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00147277
First received: September 6, 2005
Last updated: June 26, 2009
Last verified: June 2009
Results First Received: November 20, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Tachycardia, Ventricular
Ventricular Fibrillation
Intervention: Device: Implantable Cardiac Defibrillator

  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
No text entered.

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
8 Pulses Anti-Tachycardia Pacing (ATP) 8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
15 Pulses Anti-Tachycardia Pacing (ATP) 15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Participant Flow:   Overall Study
    8 Pulses Anti-Tachycardia Pacing (ATP)     15 Pulses Anti-Tachycardia Pacing (ATP)  
STARTED     475     450  
COMPLETED     475     450  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
8 Pulses Anti-Tachycardia Pacing (ATP) 8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
15 Pulses Anti-Tachycardia Pacing (ATP) 15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
Total Total of all reporting groups

Baseline Measures
    8 Pulses Anti-Tachycardia Pacing (ATP)     15 Pulses Anti-Tachycardia Pacing (ATP)     Total  
Number of Participants  
[units: participants]
  475     450     925  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     214     203     417  
>=65 years     261     247     508  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 10.9     63.4  ± 12.2     63.7  ± 11.6  
Gender  
[units: participants]
     
Female     66     48     114  
Male     409     402     811  
Region of Enrollment  
[units: participants]
     
Italy     180     169     349  
Germany     109     106     215  
France     84     77     161  
Spain     76     75     151  
Portugal     7     8     15  
Belgium     8     7     15  
Israel     9     6     15  
United Kingdom     2     2     4  



  Outcome Measures

1.  Primary:   Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)   [ Time Frame: one year ]

2.  Secondary:   Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Percent Reduction in Shocks Delivered Per Patient for Treating FVT   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Compare Likelihood of Syncopal Events Associated With FVT   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Evaluate Different Possible Predictors of ATP Success   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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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.


Results Point of Contact:  
Name/Title: Laura Manotta
Organization: Medtronic Italia S.p.A.
phone: 003902241371
e-mail: laura.manotta@medtronic.com


Publications:

ClinicalTrials.gov Identifier: NCT00147277     History of Changes
Other Study ID Numbers: 900AD
Study First Received: September 6, 2005
Results First Received: November 20, 2008
Last Updated: June 26, 2009
Health Authority: Italy: Ministry of Health