Tachycardia, VentricularPhase 4ADVANCE-CRTDNCT00147290
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
A Phase 4 study testing Implantable Cardiac Defibrillator in people with Tachycardia, Ventricular and Ventricular Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular, Ventricular Fibrillation
- What is being tested?
- Implantable Cardiac Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2004to Jan 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADVANCE CRT - D: ATP Delivery for Painless 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.
Read the 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
- Conditions
- Tachycardia, Ventricular, Ventricular Fibrillation
- Being tested
- Implantable Cardiac Defibrillator
- Keywords
- ATP, Tachycardia, CRT-D
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardiac DefibrillatorDevice
Also called ICD
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
| Study group | Role | What they receive |
|---|---|---|
| BiV | Experimental | ATP therapies are delivered in both the ventricles Receives: Device: Implantable Cardiac Defibrillator |
| RV | Active comparator | ATP delivered only in the right ventricle Receives: Device: Implantable Cardiac Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (4)
Compare Efficacy of the First BiV and RV ATP to Terminate FVT
Measured: one year
Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT
Measured: one year
Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT
Measured: one year
Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionApr 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maurizio Gasparini, Dr., Principal investigator, Istituto Clinico Humanitas Mirasole SpAMario Bocchiardo, Dr., Principal investigator, Ospedale Civile di AstiAntonio Curnis, Dr., Principal investigator, Spedali Civili di BresciaRafael Peinado, Dr., Principal investigator, La Paz MadridPhilippe Mabo, Prof., Principal investigator, Rennes University HospitalThomas Lavergne, Dr., Principal investigator, E. H. Pompidou - ParisFrederic Anselme, Dr., Principal investigator, University Hospital, RouenJoerg Schwab, Dr., Principal investigator, University Clinic - Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147290
- Sponsor's protocol ID
- 400ACRT
- Acronym
- ADVANCE-CRTD
- Status last verified
- Aug 2015
- First submitted
- 6 Sep 2005
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16684023Landolina 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.
PubMed 34392257Gasparini 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.
PubMed 29251799Gasparini 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.
PubMed 20569728
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy
- ClinicalTrials.gov ID
- NCT00147290
- Acronym / sponsor ID
- ADVANCE-CRTD / 400ACRT
- Conditions
- Tachycardia, Ventricular, Ventricular Fibrillation
- Keywords
- ATP, Tachycardia, CRT-D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Posted 10 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiV | Experimental | Device: Implantable Cardiac DefibrillatorATP therapies are delivered in both the ventricles |
| RV | Active comparator | Device: Implantable Cardiac DefibrillatorATP delivered only in the right ventricle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardiac DefibrillatorAlso: ICDImplantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window | Device | BiV, RV |
Primary outcome
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.
4 secondary outcomes
Compare Efficacy of the First BiV and RV ATP to Terminate FVT
Time frame: one year
Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT
Time frame: one year
Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT
Time frame: one year
Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16684023Schwab 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.
- Derived from this study: PubMed 34392257Landolina 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.
- Derived from this study: PubMed 29251799Gasparini 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.
- Derived from this study: PubMed 20569728Gasparini 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.
Related trials for Tachycardia, Ventricular
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Gasparini, Dr. principal investigator
Istituto Clinico Humanitas Mirasole SpA
Mario Bocchiardo, Dr. principal investigator
Ospedale Civile di Asti
Antonio Curnis, Dr. principal investigator
Spedali Civili di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantable Cardiac Defibrillator in people with Tachycardia, Ventricular and Ventricular Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00147290, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.