ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy - Full Text View

Sponsored by:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00147290

Purpose

To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.

The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in a prospective, controlled and randomized study.

Condition	Intervention	Phase
Tachycardia, Ventricular Ventricular Fibrillation	Device: Defibrillator	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

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

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia when delivered in the right ventricle only versus both ventricles resulting in a 10 % difference in favour of BIV ATP. [ Time Frame: one year ]

Secondary Outcome Measures:

Compare efficacy of:the first BiV and RV ATP to terminate FVT [ Time Frame: one year ]
Compare efficacy of the first BiV and RV ATP to terminate slow VT [ Time Frame: one year ]
Compare efficacy of BiV and RV ATP (all ATP therapies) to terminate slow VT [ Time Frame: one year ]
Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF [ Time Frame: one year ]

Enrollment:	535
Study Start Date:	February 2004
Study Completion Date:	April 2007

Arms	Assigned Interventions
BiV: Experimental ATP therapies are delivered in both the ventricles	Device: Defibrillator Implantable defibrillator
RV: Active Comparator ATP delivered only in the right ventricle	Device: Defibrillator Implantable defibrillator

Detailed Description:

Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the right ventricle (RV) only versus both ventricles (BiV) resulting in a 10 % difference in favour of BIV ATP

Secondary objectives:

Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate fast ventricular tachycardia (FVT)
Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate slow ventricular tachycardia (slow VT)
Compare efficacy of BiV and RV ATP (all ATP therapies) to terminate slow ventricular tachycardia (slow VT)
Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CRT + ICD indications (Class I-IIA) according to the guidelines
Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or BIV-ATP
Patients in chronic AF who undergo a complete AV ablation and that the complete AV block is confirmed at PHD

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
Replacements and upgrades
Epicardial lead
Mechanical tricuspid valve
Ventricular Tachyarrhythmias associated with reversible causes
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147290

Locations

Italy, Milan
Medtronic Italia SpA
Sesto San Giovanni, Milan, Italy, 20099

Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

Principal Investigator:	Maurizio Gasparini, Dr.	Istituto Clinico Humanitas Mirasole SpA
Principal Investigator:	Mario Bocchiardo, Dr.	Ospedale Civile di Asti
Principal Investigator:	Antonio Curnis, Dr.	Spedali Civili di Brescia
Principal Investigator:	Rafael Peinado, Dr.	La Paz Madrid
Principal Investigator:	Philippe Mabo, Prof.	University Hospital - Rennes
Principal Investigator:	Thomas Lavergne, Dr.	E. H. Pompidou - Paris
Principal Investigator:	Frederic Anselme, Dr.	University Hospital, Rouen
Principal Investigator:	Joerg Schwab, Dr.	University Clinic - Bonn

More Information

Publications:

Schwab JO, Gasparini M, Anselme F, Mabo P, Peinado R, Lavergne T, Bocchiardo M, Mascioli G, Passardi M, Mainardis M. Right ventricular versus biventricular antitachycardia pacing in the termination of ventricular tachyarrhythmia in patients receiving cardiac resynchronization therapy: the ADVANCE CRT-D trial. J Cardiovasc Electrophysiol. 2006 May;17(5):504-7.

Study ID Numbers:	400ACRT
Study First Received:	September 6, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00147290
Health Authority:	Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:

ATP
Tachycardia
CRT-D

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Paroxysmal ventricular fibrillation

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009