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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00617175
First received: February 4, 2008
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Heart Disease
Device: Implantable Defibrillator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1902
Study Start Date: March 2008
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617175

  Show 91 Study Locations
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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

No publications provided by Medtronic Bakken Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00617175     History of Changes
Other Study ID Numbers: ADVANCE III, ADVANCE III
Study First Received: February 4, 2008
Results First Received: August 30, 2012
Last Updated: January 21, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:
Implantable Cardiac Defibrillator
therapies reduction
Shocks
Quality of Life

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014