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

ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Tachycardia, Ventricular
• Intervention / Treatment: Device: Implantable Cardiac 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

• Study Type: Interventional
• Enrollment (Actual): 526
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.	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.	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare Efficacy of the First BiV and RV ATP to Terminate FVT	one year
Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT	one year
Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT	one year
Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF	one year

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• 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., Rennes University Hospital; 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

Publications and helpful links

General 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. doi: 10.1111/j.1540-8167.2006.00433.x.
• Landolina M, Boriani G, Biffi M, Cattafi G, Capucci A, Dello Russo A, Facchin D, Rordorf R, Sagone A, Del Greco M, Morani G, Nicolis D, Meloni S, Grammatico A, Gasparini M. Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor? J Cardiovasc Med (Hagerstown). 2022 Jan 1;23(1):42-48. doi: 10.2459/JCM.0000000000001236.
• Gasparini M, Kloppe A, Lunati M, Anselme F, Landolina M, Martinez-Ferrer JB, Proclemer A, Morani G, Biffi M, Ricci R, Rordorf R, Mangoni L, Manotta L, Grammatico A, Leyva F, Boriani G. Atrioventricular junction ablation in patients with atrial fibrillation treated with cardiac resynchronization therapy: positive impact on ventricular arrhythmias, implantable cardioverter-defibrillator therapies and hospitalizations. Eur J Heart Fail. 2018 Oct;20(10):1472-1481. doi: 10.1002/ejhf.1117. Epub 2017 Dec 18.
• Gasparini M, Anselme F, Clementy J, Santini M, Martinez-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. doi: 10.1016/j.ahj.2010.02.007.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: September 6, 2005
• First Submitted That Met QC Criteria: September 6, 2005
• First Posted (Estimated): September 7, 2005

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Tachycardia; ATP; CRT-D
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation
• Other Study ID Numbers: 400ACRT