Clinical trial NCT00147277: ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Official title: ADVANCE-D: ATP Delivery for Painless ICD Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia, Ventricular
Ventricular Fibrillation
Keywords: ATP
Thachy
FVT
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 925
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: 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.

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 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

Primary outcomes:
measure: Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)
timeFrame: one year
Secondary outcomes:
measure: Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention
timeFrame: one year
measure: Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms
timeFrame: one year
measure: Percent Reduction in Shocks Delivered Per Patient for Treating FVT
timeFrame: one year
measure: Compare Likelihood of Syncopal Events Associated With FVT
timeFrame: one year
measure: Evaluate Different Possible Predictors of ATP Success
timeFrame: one year
Other outcomes:
Locations:
city: Sesto San Giovanni
country: Italy
facility: Medtronic Italia SpA
state: MI
Study officials:
affiliation: Ospedale Niguarda Cà Granda - Milano
name: Maurizio Lunati, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Policlinico S. Donato Milanese
name: Riccardo Cappato, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: San Filippo Neri - Roma
name: Massimo Santini, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Gregorio Marañón, Madrid
name: Angel Arenal, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz
name: Josè Luis Merino, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Arcadio Garcia-Alberola, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic Center Dortmund
name: Johann Mermi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Pascal Defaye, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1540-8159.2006.00488.x.