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

This study has been completed.
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00147290
First received: September 6, 2005
Last updated: June 11, 2009
Last verified: June 2009

September 6, 2005
June 11, 2009
February 2004
April 2007   (final data collection date for primary outcome measure)
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. [ Time Frame: one year ] [ Designated as safety issue: No ]
Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia when delivered in the right ventricle only versus both ventricles resulting in a 10 % difference in favour of BIV ATP.
Complete list of historical versions of study NCT00147290 on ClinicalTrials.gov Archive Site
  • Compare Efficacy of the First BiV and RV ATP to Terminate FVT [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Compare efficacy of:
  • the first BiV and RV ATP to terminate FVT
  • the first BiV and RV ATP to terminate slow VT
  • BiV and RV ATP (all ATP therapies) to terminate slow VT
  • Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF
Not Provided
Not Provided
 
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy

To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.

The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in a prospective, controlled and randomized study.

Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the right ventricle (RV) only versus both ventricles (BiV) resulting in a 10 % difference in favour of BIV ATP

Secondary objectives:

  • Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate fast ventricular tachycardia (FVT)
  • Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate slow ventricular tachycardia (slow VT)
  • Compare efficacy of BiV and RV ATP (all ATP therapies) to terminate slow ventricular tachycardia (slow VT)
  • Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Tachycardia, Ventricular
  • Ventricular Fibrillation
Device: Implantable Cardiac Defibrillator
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
Other Name: ICD
  • Experimental: BiV
    ATP therapies are delivered in both the ventricles
    Intervention: Device: Implantable Cardiac Defibrillator
  • Active Comparator: RV
    ATP delivered only in the right ventricle
    Intervention: Device: Implantable Cardiac Defibrillator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
526
January 2008
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CRT + ICD indications (Class I-IIA) according to the guidelines
  • Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or BIV-ATP
  • Patients in chronic AF who undergo a complete AV ablation and that the complete AV block is confirmed at PHD

Exclusion Criteria:

  • Patient's life expectancy less than 1 year due to a non cardiac chronic disease
  • Patient on heart transplant list which is expected in < 1 year
  • Patient's age less than 18 years
  • Replacements and upgrades
  • Epicardial lead
  • Mechanical tricuspid valve
  • Ventricular Tachyarrhythmias associated with reversible causes
  • Unwillingness or inability to provide written informed consent
  • Enrollment in, or intention to participate in, another clinical study during the course of this study
  • Inaccessibility for follow-up at the study center
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00147290
400ACRT
No
Elisabetta Santi, Medtronic
Medtronic Bakken Research Center
Not Provided
Principal Investigator: Maurizio Gasparini, Dr. Istituto Clinico Humanitas Mirasole SpA
Principal Investigator: Mario Bocchiardo, Dr. Ospedale Civile di Asti
Principal Investigator: Antonio Curnis, Dr. Spedali Civili di Brescia
Principal Investigator: Rafael Peinado, Dr. La Paz Madrid
Principal Investigator: Philippe Mabo, Prof. Rennes University Hospital
Principal Investigator: Thomas Lavergne, Dr. E. H. Pompidou - Paris
Principal Investigator: Frederic Anselme, Dr. University Hospital, Rouen
Principal Investigator: Joerg Schwab, Dr. University Clinic - Bonn
Medtronic Bakken Research Center
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP