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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
Enrollment 526

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Right Ventricle (RV) Biventricular (BiV)
Hide Arm/Group Description Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
Period Title: Overall Study
Started 266 260
Completed 266 260
Not Completed 0 0
Arm/Group Title Right Ventricle (RV) Biventricular (BiV) Total
Hide Arm/Group Description Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles Total of all reporting groups
Overall Number of Baseline Participants 266 260 526
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 266 participants 260 participants 526 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
94
  35.3%
95
  36.5%
189
  35.9%
>=65 years
172
  64.7%
165
  63.5%
337
  64.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 266 participants 260 participants 526 participants
66.6  (10.2) 66.8  (9.5) 66.7  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 266 participants 260 participants 526 participants
Female
35
  13.2%
42
  16.2%
77
  14.6%
Male
231
  86.8%
218
  83.8%
449
  85.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 266 participants 260 participants 526 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
1.Primary Outcome
Title Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.
Hide Description Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with GEE method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.
Time Frame one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Right Ventricle (RV) Biventricular (BiV)
Hide Arm/Group Description:
Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
Overall Number of Participants Analyzed 260 266
Measure Type: Number
Unit of Measure: Percent of VT episodes terminated
64.7 68.2
2.Secondary Outcome
Title Compare Efficacy of the First BiV and RV ATP to Terminate FVT
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
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
Publications: