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

Primary Purpose

Heart Disease

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Implantable Defibrillator

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring Implantable Cardiac Defibrillator, therapies reduction, Shocks, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long NID

Short NID

Arm Description

Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia

Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia

Outcomes

Primary Outcome Measures

For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.

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.

Full Information

NCT ID

NCT00617175

First Posted

February 4, 2008

Last Updated

March 23, 2016

Sponsor

Medtronic Bakken Research Center

1. Study Identification

Unique Protocol Identification Number

NCT00617175

Brief Title

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

Acronym

ADVANCEIII

Official Title

ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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: 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. 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. Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms. Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms). Describe the economic impact and the quality of life consequences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Disease

Keywords

Implantable Cardiac Defibrillator, therapies reduction, Shocks, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1902 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Long NID

Arm Type

Experimental

Arm Description

Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia

Arm Title

Short NID

Arm Type

Active Comparator

Arm Description

Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia

Intervention Type

Device

Intervention Name(s)

Implantable Defibrillator

Intervention Description

Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia

Intervention Type

Device

Intervention Name(s)

Implantable Defibrillator

Intervention Description

number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia

Primary Outcome Measure Information:

Title

For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.

Description

Time Frame

From enrollment to study completion or exit whichever occured first

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: