search
Back to results

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

Primary Purpose

Tachycardia, Ventricular, Ventricular Fibrillation

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Implantable Cardiac Defibrillator
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia, Ventricular focused on measuring ATP, Tachycardia, CRT-D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medtronic Italia SpA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BiV

RV

Arm Description

ATP therapies are delivered in both the ventricles

ATP delivered only in the right ventricle

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compare Efficacy of the First BiV and RV ATP to Terminate FVT
Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT
Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT
Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF

Full Information

First Posted
September 6, 2005
Last Updated
August 12, 2015
Sponsor
Medtronic Bakken Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00147290
Brief Title
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Acronym
ADVANCE-CRTD
Official Title
ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular, Ventricular Fibrillation
Keywords
ATP, Tachycardia, CRT-D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BiV
Arm Type
Experimental
Arm Description
ATP therapies are delivered in both the ventricles
Arm Title
RV
Arm Type
Active Comparator
Arm Description
ATP delivered only in the right ventricle
Intervention Type
Device
Intervention Name(s)
Implantable Cardiac Defibrillator
Other Intervention Name(s)
ICD
Intervention Description
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
Primary Outcome Measure Information:
Title
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Compare Efficacy of the First BiV and RV ATP to Terminate FVT
Time Frame
one year
Title
Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT
Time Frame
one year
Title
Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT
Time Frame
one year
Title
Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Gasparini, Dr.
Organizational Affiliation
Istituto Clinico Humanitas Mirasole SpA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario Bocchiardo, Dr.
Organizational Affiliation
Ospedale Civile di Asti
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Curnis, Dr.
Organizational Affiliation
Spedali Civili di Brescia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafael Peinado, Dr.
Organizational Affiliation
La Paz Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Mabo, Prof.
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Lavergne, Dr.
Organizational Affiliation
E. H. Pompidou - Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederic Anselme, Dr.
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joerg Schwab, Dr.
Organizational Affiliation
University Clinic - Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medtronic Italia SpA
City
Sesto San Giovanni
State/Province
Milan
ZIP/Postal Code
20099
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16684023
Citation
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.
Results Reference
background
PubMed Identifier
34392257
Citation
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.
Results Reference
derived
PubMed Identifier
29251799
Citation
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.
Results Reference
derived
PubMed Identifier
20569728
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs