Clinical trial NCT00147290: ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Official title: ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia, Ventricular
Ventricular Fibrillation
Keywords: ATP
Tachycardia
CRT-D
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.
timeFrame: one year
Secondary outcomes:
measure: Compare Efficacy of the First BiV and RV ATP to Terminate FVT
timeFrame: one year
measure: Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT
timeFrame: one year
measure: Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT
timeFrame: one year
measure: Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF
timeFrame: one year
Other outcomes:
Locations:
city: Sesto San Giovanni
country: Italy
facility: Medtronic Italia SpA
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas Mirasole SpA
name: Maurizio Gasparini, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Civile di Asti
name: Mario Bocchiardo, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Spedali Civili di Brescia
name: Antonio Curnis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: La Paz Madrid
name: Rafael Peinado, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Philippe Mabo, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: E. H. Pompidou - Paris
name: Thomas Lavergne, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Frederic Anselme, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinic - Bonn
name: Joerg Schwab, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.