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

Sponsored by:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00147277

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	ADVANCE-D: ATP Delivery for Painless ICD Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention [ Time Frame: one year ] [ Designated as safety issue: No ]
Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms [ Time Frame: one year ] [ Designated as safety issue: No ]
Percent Reduction in Shocks Delivered Per Patient for Treating FVT [ Time Frame: one year ] [ Designated as safety issue: No ]
Compare Likelihood of Syncopal Events Associated With FVT [ Time Frame: one year ] [ Designated as safety issue: No ]
Evaluate Different Possible Predictors of ATP Success [ Time Frame: one year ] [ Designated as safety issue: No ]

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
8 pulses: Active Comparator 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
15 pulses: Experimental 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147277

Locations

Italy, MI
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 La Paz - Madrid
Principal Investigator:	Arcadio Garcia-Alberola, Dr.	Hospital Virgen de la Arrixaca - Murcia
Principal Investigator:	Johann Mermi, Dr.	Clinic Center Dortmund
Principal Investigator:	Pascal Defaye, Dr.	University Hospital, Grenoble

More Information

Publications:

Lunati M, Defaye P, Mermi J, Garcia-Alberola A, Merino JL, Arenal A, Cappato R, Navarro X, Passardi M, Santini M. Improvement of quality of life by means of antitachy pacing: from PainFREE to the ADVANCE-D Trial. Pacing Clin Electrophysiol. 2006 Dec;29 Suppl 2:S35-9. Review.

Study ID Numbers:	900AD
Study First Received:	September 6, 2005
Results First Received:	November 20, 2008
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00147277 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:

ATP
Thachy
FVT

Study placed in the following topic categories:

Paroxysmal Ventricular Fibrillation
Heart Diseases
Tachycardia

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 04, 2009