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

Ventricular Fibrillation Clinical Trial

— ADVANCE-CRTD  

Official title:

ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147290
• Other study ID #: 400ACRT
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: August 12, 2015
• Start date: February 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

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: January 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Compare Efficacy of the First BiV and RV ATP to Terminate FVT		one year	No
Secondary	Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT		one year	No
Secondary	Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT		one year	No
Secondary	Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF		one year	No