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Completed

NCT Number: NCT00147290

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medtronic Italia SpA

Sesto San Giovanni, Milan, 20099, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Cardiac Defibrillator

Device

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

Other names: ICD

Primary outcomes

  1. Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.

    Time frame: one year

    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.

Secondary outcomes

  1. Compare Efficacy of the First BiV and RV ATP to Terminate FVT

    Time frame: one year

  2. Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT

    Time frame: one year

  3. Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT

    Time frame: one year

  4. Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy

Acronym: ADVANCE-CRTD

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 7, 2005
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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