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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: August 12, 2015
Last verified: August 2015
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
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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
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 
Overall Participants Analyzed 
[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: August 12, 2015
Health Authority: Italy: Ministry of Health