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

Ventricular Fibrillation Clinical Trial

— ADVANCE_D  

Official title:

ADVANCE-D: ATP Delivery for Painless ICD Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147277
• Other study ID #: 900AD
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: August 12, 2015
• Start date: March 2004
• Est. completion date: January 2008

Study information

• Verified date: August 2015
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 925
• Est. completion date: January 2008
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation

Intervention

Device:
• Implantable Cardiac Defibrillator
Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone

Locations

Country	Name	City	State
Italy	Medtronic Italia SpA	Sesto San Giovanni	MI

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)	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	No
Secondary	Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention		one year	No
Secondary	Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms		one year	No
Secondary	Percent Reduction in Shocks Delivered Per Patient for Treating FVT		one year	No
Secondary	Compare Likelihood of Syncopal Events Associated With FVT		one year	No
Secondary	Evaluate Different Possible Predictors of ATP Success		one year	No