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

Sponsor:	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: Implantable Cardiac Defibrillator	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia 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 (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare Efficacy of the First BiV and RV ATP to Terminate FVT [ Time Frame: one year ] [ Designated as safety issue: No ]
Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT [ Time Frame: one year ] [ Designated as safety issue: No ]
Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT [ Time Frame: one year ] [ Designated as safety issue: No ]
Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	526
Study Start Date:	February 2004
Study Completion Date:	January 2008
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BiV ATP therapies are delivered in both the ventricles	Device: Implantable Cardiac Defibrillator Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window Other Name: ICD
Active Comparator: RV ATP delivered only in the right ventricle	Device: Implantable Cardiac Defibrillator Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window Other Name: ICD

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
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gasparini M, Anselme F, Clementy J, Santini M, Martínez-Ferrer J, De Santo T, Santi E, Schwab JO; ADVANCE CRT-D Investigators. BIVentricular versus right ventricular antitachycardia pacing to terminate ventricular tachyarrhythmias in patients receiving cardiac resynchronization therapy: the ADVANCE CRT-D Trial. Am Heart J. 2010 Jun;159(6):1116-1123.e2.

Responsible Party:	Elisabetta Santi, Medtronic
ClinicalTrials.gov Identifier:	NCT00147290 History of Changes
Other Study ID Numbers:	400ACRT
Study First Received:	September 6, 2005
Results First Received:	November 20, 2008
Last Updated:	June 11, 2009
Health Authority:	Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:

ATP
Tachycardia
CRT-D

Additional relevant MeSH terms:

Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012