To estimate and quantify the difference of efficacy of two sequences of ATP therapies (Burst 15 pulses, 88% vs. Burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as Fast VT via 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.

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

Further Study Details: 

Primary Outcomes: Compare efficacy of 2 different sequences of Burst ATP for the termination of VT (with CL of 240ms-320ms) from baseline to 12 Mo. post randomization in pts. who are treated with ATP-8 pulses, 88% versus patients who are treated with ATP-15 pulses, 88%
Secondary Outcomes: *efficacy of ATP in successfully treating FVT for pts in primary and secondary prevention; *acceleration rate or degenerated into VF of ATP for treating FVT in the 2 arms; *% reduction in shocks delivered per pt for treating FVT; *Compare likelihood of syncopal events associated with FVT; *Evaluate different possible predictors of ATP success
Expected Total Enrollment:  900

Main objective: Compare & quantify efficacy of two different sequences of Burst ATP strategies for the termination of ventricular tachycardia (with 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, AAD, infarct zone, etc.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• ICD indications (Class I-II A) according to the guidelines (Patient with 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
• ICDs replacements and upgrading (SC ICD®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 HCM patients
• Other electrical implantable devices (Neurostimulators, etc.)
• Mechanical tricuspid valve

Please refer to this study by ClinicalTrials.gov identifier  NCT00147277

Micaela Passardi, Ing      0039 02 24137358    micaela.passardi@medtronic.com

Italy, MI
      Medtronic Italia SpA, Sesto San Giovanni,  MI,  20099,  Italy; Recruiting

Study chairs or principal investigators

Maurizio Lunati, Dr.,  Principal Investigator,  Ospedale Niguarda Cà Granda - Milano   
Riccardo Cappato, Dr.,  Principal Investigator,  Istituto Policlinico S. Donato Milanese   
Massimo Santini, Prof.,  Principal Investigator,  San Filippo Neri - Roma   
Angel Arenal, Dr.,  Principal Investigator,  Hospital Gregorio Marañón - Madrid   
Josè Luis Merino, Dr.,  Principal Investigator,  Hospital La Paz - Madrid   
Arcadio Garcia-Alberola, Dr.,  Principal Investigator,  Hospital Virgen de la Arrixaca - Murcia   
Johann Mermi, Dr.,  Principal Investigator,  Clinic Center Dortmund   
Pascal Defaye, Dr.,  Principal Investigator,  University Hospital Grenoble   

Study ID Numbers:  900AD
Last Updated:  September 6, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00147277
Health Authority: Italy: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13