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

NCT00147277 | Completed Phase 4 Results

• 1 other identifier: 900AD
• Study Type: interventional
• Target: 925
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Keywords

ATP; Thachy; FVT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention

  one year

• Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms

  one year

• Percent Reduction in Shocks Delivered Per Patient for Treating FVT

  one year

• Compare Likelihood of Syncopal Events Associated With FVT

  one year

• Evaluate Different Possible Predictors of ATP Success

  one year

Study Arms (2)

8 pulses

ACTIVE COMPARATOR

8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Device: Implantable Cardiac Defibrillator

15 pulses

EXPERIMENTAL

15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Device: Implantable Cardiac Defibrillator

Interventions

Implantable Cardiac Defibrillator DEVICE

Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone

15 pulses; 8 pulses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Medtronic Italia SpA

Sesto San Giovanni, MI, 20099, Italy

Location

Related 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. doi: 10.1111/j.1540-8159.2006.00488.x.

  PMID: 17169131 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laura Manotta
• Organization: Medtronic Italia S.p.A.

laura.manotta@medtronic.com

003902241371

Study Officials

• Maurizio Lunati, Dr.

  Ospedale Niguarda Cà Granda - Milano

  PRINCIPAL INVESTIGATOR

• Riccardo Cappato, Dr.

  Istituto Policlinico S. Donato Milanese

  PRINCIPAL INVESTIGATOR

• Massimo Santini, Prof.

  San Filippo Neri - Roma

  PRINCIPAL INVESTIGATOR

• Angel Arenal, Dr.

  Hospital Gregorio Marañón, Madrid

  PRINCIPAL INVESTIGATOR

• Josè Luis Merino, Dr.

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Arcadio Garcia-Alberola, Dr.

  Hospital Universitario Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

• Johann Mermi, Dr.

  Clinic Center Dortmund

  PRINCIPAL INVESTIGATOR

• Pascal Defaye, Dr.

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: March 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2008
• Last Updated: July 11, 2025
• Results First Posted: May 12, 2009

Record last verified: 2015-08

Locations

IT (1)