ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00147290
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : June 10, 2009
Last Update Posted : August 13, 2015
Sponsor:
Information provided by:
Medtronic Bakken Research Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Tachycardia, Ventricular
Ventricular Fibrillation
Intervention: Device: Implantable Cardiac Defibrillator

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Right Ventricle (RV) Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
Biventricular (BiV) Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles

Participant Flow:   Overall Study
    Right Ventricle (RV)   Biventricular (BiV)
STARTED   266   260 
COMPLETED   266   260 
NOT COMPLETED   0   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Right Ventricle (RV) Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
Biventricular (BiV) Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
Total Total of all reporting groups

Baseline Measures
   Right Ventricle (RV)   Biventricular (BiV)   Total 
Overall Participants Analyzed 
[Units: Participants]
 266   260   526 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   94   95   189 
>=65 years   172   165   337 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.6  (10.2)   66.8  (9.5)   66.7  (9.8) 
Gender 
[Units: Participants]
     
Female   35   42   77 
Male   231   218   449 
Region of Enrollment 
[Units: Participants]
     
Italy   122   127   249 
France   67   61   128 
Germany   48   46   94 
Spain   22   20   42 
Israel   5   4   9 
Portugal   1   1   2 
United Kingdom   1   1   2 


  Outcome Measures

1.  Primary:   Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.   [ Time Frame: one year ]

2.  Secondary:   Compare Efficacy of the First BiV and RV ATP to Terminate FVT   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: Elisabetta Santi
Organization: Medtronic
phone: 003906328141
e-mail: elisabetta.santi@medtronic.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Elisabetta Santi, Medtronic
ClinicalTrials.gov Identifier: NCT00147290     History of Changes
Other Study ID Numbers: 400ACRT
First Submitted: September 6, 2005
First Posted: September 7, 2005
Results First Submitted: November 20, 2008
Results First Posted: June 10, 2009
Last Update Posted: August 13, 2015