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Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III (ADVANCEIII)

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ClinicalTrials.gov Identifier: NCT00617175
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : February 25, 2013
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Description
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Brief Summary:
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.

Condition or disease Intervention/treatment Phase
Heart Disease Device: Implantable Defibrillator Phase 4

Detailed Description:

Primary Objective:

The primary objective is to demonstrate a 20% reduction of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (NID) compared to a NID of 18 out of 24 in subjects with either Class I or IIA indication for ICD implantation, regardless of cardiac resynchronization capabilities.

Secondary Objectives:

  1. Evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (CL ≤ 320 ms) and for spontaneous ventricular episodes.
  2. Evaluate the efficacy of ATP in successfully treating spontaneous ventricular episodes (CL: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study.
  3. Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms.
  4. Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms).
  5. Describe the economic impact and the quality of life consequences.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1902 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
Study Start Date : March 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: Long NID
Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
 Device: Implantable Defibrillator
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
Active Comparator: Short NID
Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
 Device: Implantable Defibrillator
number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia


Outcome Measures
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Primary Outcome Measures :
  1. For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured. [ Time Frame: From enrollment to study completion or exit whichever occured first ]

    for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed.

    The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times * 100.



Secondary Outcome Measures :
  1. Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes. [ Time Frame: end of study ]

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

Inclusion Criteria:

  • Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines.
  • Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.

Exclusion Criteria:

  • ICD replacements and upgrading.
  • Brugada Syndrome, Long QT and HCM patients
  • Ventricular tachyarrhythmia associated with reversible cause.
  • Other electrical implantable devices (Neurostimulators, etc.).
  • Subject's life expectancy less than 1 year.
  • Subject on heart transplant list which is expected in less than 1 year.
  • Subject is <18 years of age, or the subject is under a minimum age that is required as defined by local law
  • Women who are pregnant or women of childbearing potential who are not on a reliable form of birth control.
  • Unwillingness or inability to provide written informed consent.
  • Enrolment in, or intention to participate in, another clinical trial.
  • Inaccessibility to come to the study center for the follow-up visits.
  • Mechanical tricuspid valve.
Contacts and Locations
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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): NCT00617175


Locations
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Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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Study Chair: Jorg O. Schwab, MD University of Bonn, Bonn, Germany
Principal Investigator: Maurizio Gasparini, MD Humanitas Hospital, Milano Italy
Principal Investigator: Maurizio Lunati, MD Niguarda Hospital, Milano, Italy
Principal Investigator: Bernd Lemke, MD Klinikum Lüdenscheid, Lüdenscheid, Germany
Principal Investigator: João Sousa, MD H. Santa Maria - Lisbon - Portugal
Principal Investigator: Andrzej Okreglicki, MD University of Cape Town, Cape Town, South Africa
Principal Investigator: Angel Arenal, MD Hospital Gregorio Marañón, Madrid, Spain
Principal Investigator: Maurits Wijffels, MD St. Antonius hospital - NIEUWEGEIN, The Netherlands
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00617175    
Other Study ID Numbers: ADVANCE III
ADVANCE III
First Posted: February 15, 2008    Key Record Dates
Results First Posted: February 25, 2013
Last Update Posted: March 24, 2016
Last Verified: March 2016
Keywords provided by Medtronic Bakken Research Center:
Implantable Cardiac Defibrillator
therapies reduction
Shocks
Quality of Life
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases