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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:
ClinicalTrials.gov Identifier:
NCT00147277
First Posted: September 7, 2005
Last Update Posted: August 13, 2015
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.
Information provided by:
Medtronic Bakken Research Center
  Purpose
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: ADVANCE-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 to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) [ Time Frame: one year ]
    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.


Secondary Outcome Measures:
  • Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention [ Time Frame: one year ]
  • Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms [ Time Frame: one year ]
  • Percent Reduction in Shocks Delivered Per Patient for Treating FVT [ Time Frame: one year ]
  • Compare Likelihood of Syncopal Events Associated With FVT [ Time Frame: one year ]
  • Evaluate Different Possible Predictors of ATP Success [ Time Frame: one year ]

Enrollment: 925
Study Start Date: March 2004
Study Completion Date: January 2008
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 8 pulses
8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
Device: Implantable Cardiac Defibrillator
Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone
Experimental: 15 pulses
15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
Device: Implantable Cardiac Defibrillator
Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone

Detailed Description:

Main objective: Compare & quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88%

Secondary objectives:

  • Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention
  • Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm
  • Compare the likelihood of syncopal events associated with spontaneous FVT episodes
  • Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes
  • Evaluate different possible predictors of ATP success: VT rate, underlying disease, Anti-Arrhythmic Drugs (AAD), infarct zone, etc.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease [CAD] or non-CAD in primary or secondary ICD prevention)
  • Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF

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
  • ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD)
  • 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
  • Ventricular tachyarrhythmias associated with reversible causes
  • Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients
  • Other electrical implantable devices (neurostimulators, etc.)
  • Mechanical tricuspid valve
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147277


Locations
Italy
Medtronic Italia SpA
Sesto San Giovanni, MI, Italy, 20099
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Maurizio Lunati, Dr. Ospedale Niguarda Cà Granda - Milano
Principal Investigator: Riccardo Cappato, Dr. Istituto Policlinico S. Donato Milanese
Principal Investigator: Massimo Santini, Prof. San Filippo Neri - Roma
Principal Investigator: Angel Arenal, Dr. Hospital Gregorio Marañón - Madrid
Principal Investigator: Josè Luis Merino, Dr. Hospital Universitario La Paz
Principal Investigator: Arcadio Garcia-Alberola, Dr. Hospital Universitario Virgen de la Arrixaca
Principal Investigator: Johann Mermi, Dr. Clinic Center Dortmund
Principal Investigator: Pascal Defaye, Dr. University Hospital, Grenoble
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00147277     History of Changes
Other Study ID Numbers: 900AD
First Submitted: September 6, 2005
First Posted: September 7, 2005
Results First Submitted: November 20, 2008
Results First Posted: May 12, 2009
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Medtronic Bakken Research Center:
ATP
Thachy
FVT

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