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

This study has been completed.
Sponsor:
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00147290
First received: September 6, 2005
Last updated: June 11, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Tachycardia, Ventricular
Ventricular Fibrillation
Device: Implantable Cardiac Defibrillator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare Efficacy of the First BiV and RV ATP to Terminate FVT [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 526
Study Start Date: February 2004
Study Completion Date: January 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BiV
ATP therapies are delivered in both the ventricles
Device: Implantable Cardiac Defibrillator
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
Other Name: ICD
Active Comparator: RV
ATP delivered only in the right ventricle
Device: Implantable Cardiac Defibrillator
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
Other Name: ICD

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147290

Locations
Italy
Medtronic Italia SpA
Sesto San Giovanni, Milan, Italy, 20099
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: 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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elisabetta Santi, Medtronic
ClinicalTrials.gov Identifier: NCT00147290     History of Changes
Other Study ID Numbers: 400ACRT
Study First Received: September 6, 2005
Results First Received: November 20, 2008
Last Updated: June 11, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:
ATP
Tachycardia
CRT-D

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014