NCT00147290

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 10, 2009

Completed
Last Updated

July 2, 2025

Status Verified

August 1, 2015

Enrollment Period

3.2 years

First QC Date

September 6, 2005

Results QC Date

November 20, 2008

Last Update Submit

June 30, 2025

Conditions

Tachycardia, VentricularVentricular Fibrillation

Keywords

ATPTachycardiaCRT-D

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

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

    one year

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

    one year

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

    one year

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

    one year

Study Arms (2)

BiV

EXPERIMENTAL

ATP therapies are delivered in both the ventricles

Device: Implantable Cardiac Defibrillator

RV

ACTIVE COMPARATOR

ATP delivered only in the right ventricle

Device: Implantable Cardiac Defibrillator

Interventions

Implantable Cardiac DefibrillatorDEVICE

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

Also known as: ICD
BiVRV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medtronic Italia SpA

Sesto San Giovanni, Milan, 20099, Italy

Location

Related Publications (4)

  • 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. doi: 10.1111/j.1540-8167.2006.00433.x.

    PMID: 16684023BACKGROUND

  • Landolina M, Boriani G, Biffi M, Cattafi G, Capucci A, Dello Russo A, Facchin D, Rordorf R, Sagone A, Del Greco M, Morani G, Nicolis D, Meloni S, Grammatico A, Gasparini M. Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor? J Cardiovasc Med (Hagerstown). 2022 Jan 1;23(1):42-48. doi: 10.2459/JCM.0000000000001236.

    PMID: 34392257DERIVED

  • Gasparini M, Kloppe A, Lunati M, Anselme F, Landolina M, Martinez-Ferrer JB, Proclemer A, Morani G, Biffi M, Ricci R, Rordorf R, Mangoni L, Manotta L, Grammatico A, Leyva F, Boriani G. Atrioventricular junction ablation in patients with atrial fibrillation treated with cardiac resynchronization therapy: positive impact on ventricular arrhythmias, implantable cardioverter-defibrillator therapies and hospitalizations. Eur J Heart Fail. 2018 Oct;20(10):1472-1481. doi: 10.1002/ejhf.1117. Epub 2017 Dec 18.

    PMID: 29251799DERIVED

  • Gasparini M, Anselme F, Clementy J, Santini M, Martinez-Ferrer J, De Santo T, Santi E, Schwab JO; ADVANCE CRT-D Investigators. BIVentricular versus right ventricular antitachycardia pacing to terminate ventricular tachyarrhythmias in patients receiving cardiac resynchronization therapy: the ADVANCE CRT-D Trial. Am Heart J. 2010 Jun;159(6):1116-1123.e2. doi: 10.1016/j.ahj.2010.02.007.

    PMID: 20569728DERIVED

MeSH Terms

Conditions

Tachycardia, VentricularVentricular FibrillationTachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Elisabetta Santi
Organization
Medtronic
elisabetta.santi@medtronic.com
003906328141

Study Officials

  • Maurizio Gasparini, Dr.

    Istituto Clinico Humanitas Mirasole SpA

    PRINCIPAL INVESTIGATOR

  • Mario Bocchiardo, Dr.

    Ospedale Civile di Asti

    PRINCIPAL INVESTIGATOR

  • Antonio Curnis, Dr.

    Spedali Civili di Brescia

    PRINCIPAL INVESTIGATOR

  • Rafael Peinado, Dr.

    La Paz Madrid

    PRINCIPAL INVESTIGATOR

  • Philippe Mabo, Prof.

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Thomas Lavergne, Dr.

    E. H. Pompidou - Paris

    PRINCIPAL INVESTIGATOR

  • Frederic Anselme, Dr.

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

  • Joerg Schwab, Dr.

    University Clinic - Bonn

    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

February 1, 2004

Primary Completion

April 1, 2007

Study Completion

January 1, 2008

Last Updated

July 2, 2025

Results First Posted

June 10, 2009

Record last verified: 2015-08

Locations

IT(1)