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
  Purpose

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.


Condition Intervention Phase
Tachycardia, Ventricular
Ventricular Fibrillation
Device: Implantable Cardiac Defibrillator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 526
Study Start Date: February 2004
Study Completion Date: January 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BiV
ATP therapies are delivered in both the ventricles
Device: Implantable Cardiac Defibrillator
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
Other Name: ICD
Active Comparator: RV
ATP delivered only in the right ventricle
Device: Implantable Cardiac Defibrillator
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
Other Name: ICD

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147290

Locations
Italy
Medtronic Italia SpA
Sesto San Giovanni, Milan, Italy, 20099
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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. University Hospital, Rennes
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
  More Information

Publications:
Additional 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
Study First Received: September 6, 2005
Results First Received: November 20, 2008
Last Updated: June 11, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:
ATP
Tachycardia
CRT-D

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014