ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy - Clinical Trial for Tachycardia, Ventricular | NCT00147277

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Implantable Cardiac Defibrillator

About this trial

This is an interventional treatment trial for Tachycardia, Ventricular focused on measuring ATP, Thachy, FVT

Eligibility Criteria

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

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

Sites / Locations

Medtronic Italia SpA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

8 pulses

15 pulses

Arm Description

8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Outcomes

Primary Outcome Measures

Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)

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

Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms

Percent Reduction in Shocks Delivered Per Patient for Treating FVT

Compare Likelihood of Syncopal Events Associated With FVT

Evaluate Different Possible Predictors of ATP Success

Full Information

NCT ID

NCT00147277

First Posted

September 6, 2005

Last Updated

August 12, 2015

Sponsor

Medtronic Bakken Research Center

1. Study Identification

Unique Protocol Identification Number

NCT00147277

Brief Title

ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy

Acronym

ADVANCE_D

Official Title

ADVANCE-D: ATP Delivery for Painless ICD Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Tachycardia, Ventricular, Ventricular Fibrillation

Keywords

ATP, Thachy, FVT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

925 (Actual)

8. Arms, Groups, and Interventions

Arm Title

8 pulses

Arm Type

Active Comparator

Arm Description

8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Arm Title

15 pulses

Arm Type

Experimental

Arm Description

15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Intervention Type

Device

Intervention Name(s)

Implantable Cardiac Defibrillator

Intervention Description

Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone

Primary Outcome Measure Information:

Title

Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)

Description

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.

Time Frame

one year

Secondary Outcome Measure Information:

Title

Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention

Time Frame

one year

Title

Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms

Time Frame

one year

Title

Percent Reduction in Shocks Delivered Per Patient for Treating FVT

Time Frame

one year

Title

Compare Likelihood of Syncopal Events Associated With FVT

Time Frame

one year

Title

Evaluate Different Possible Predictors of ATP Success

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials: