Tachycardia, VentricularPhase 4ADVANCE_DNCT00147277
ADVANCE-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
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I… 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
- 925 participants
- Where
- 1 siteItaly
- Study dates
- Mar 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
- ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease [CAD] or non-CAD in primary or secondary ICD prevention)
- Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF
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
- ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD)
- Unwillingness or inability to provide written informed consent
- Enrollment in, or intention to participate in, another clinical study during the course of this study
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- Inaccessibility for follow-up at the study center
- Ventricular tachyarrhythmias associated with reversible causes
- Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients
- Other electrical implantable devices (neurostimulators, etc.)
- Mechanical tricuspid valve
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADVANCE-D: ATP Delivery for Painless ICD Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.
Read the detailed description
Main objective: Compare \& quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88%
Secondary objectives:
- Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention
- Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm
- Compare the likelihood of syncopal events associated with spontaneous FVT episodes
- Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes
- Evaluate different possible predictors of ATP success: VT rate, underlying disease, Anti-Arrhythmic Drugs (AAD), infarct zone, etc.
- Conditions
- Tachycardia, Ventricular, Ventricular Fibrillation
- Being tested
- Implantable Cardiac Defibrillator
- Keywords
- ATP, Thachy, FVT
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardiac DefibrillatorDevice
Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone
| Study group | Role | What they receive |
|---|---|---|
| 8 pulses | Active comparator | 8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) Receives: Device: Implantable Cardiac Defibrillator |
| 15 pulses | Experimental | 15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) 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 to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)
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 (5)
Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention
Measured: one year
Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms
Measured: one year
Percent Reduction in Shocks Delivered Per Patient for Treating FVT
Measured: one year
Compare Likelihood of Syncopal Events Associated With FVT
Measured: one year
Evaluate Different Possible Predictors of ATP Success
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 startMar 2004
- Primary completionJan 2006
- 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 (1)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
- 925 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Maurizio Lunati, Dr., Principal investigator, Ospedale Niguarda Cà Granda - MilanoRiccardo Cappato, Dr., Principal investigator, Istituto Policlinico S. Donato MilaneseMassimo Santini, Prof., Principal investigator, San Filippo Neri - RomaAngel Arenal, Dr., Principal investigator, Hospital General Universitario Gregorio MarañonJosè Luis Merino, Dr., Principal investigator, Hospital Universitario La PazArcadio Garcia-Alberola, Dr., Principal investigator, Hospital Universitario Virgen de la ArrixacaJohann Mermi, Dr., Principal investigator, Clinic Center DortmundPascal Defaye, Dr., Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147277
- Sponsor's protocol ID
- 900AD
- Acronym
- ADVANCE_D
- Status last verified
- Aug 2015
- First submitted
- 6 Sep 2005
- Last updated
- 11 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lunati M, Defaye P, Mermi J, Garcia-Alberola A, Merino JL, Arenal A, Cappato R, Navarro X, Passardi M, Santini M. Improvement of quality of life by means of antitachy pacing: from PainFREE to the ADVANCE-D Trial. Pacing Clin Electrophysiol. 2006 Dec;29 Suppl 2:S35-9. doi: 10.1111/j.1540-8159.2006.00488.x.
PubMed 17169131
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANCE-D: ATP Delivery for Painless ICD Therapy
- ClinicalTrials.gov ID
- NCT00147277
- Acronym / sponsor ID
- ADVANCE_D / 900AD
- Conditions
- Tachycardia, Ventricular, Ventricular Fibrillation
- Keywords
- ATP, Thachy, FVT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 925 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Posted 12 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.
Detailed description
Main objective: Compare \& quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88%
Secondary objectives:
- Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention
- Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm
- Compare the likelihood of syncopal events associated with spontaneous FVT episodes
- Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes
- Evaluate different possible predictors of ATP success: VT rate, underlying disease, Anti-Arrhythmic Drugs (AAD), infarct zone, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 pulses | Active comparator | Device: Implantable Cardiac Defibrillator8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) |
| 15 pulses | Experimental | Device: Implantable Cardiac Defibrillator15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease [CAD] or non-CAD in primary or secondary ICD prevention)
- Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF
Key exclusion criteria (11 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
- ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD)
- Unwillingness or inability to provide written informed consent
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 DefibrillatorMedtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone | Device | 15 pulses, 8 pulses |
Primary outcome
Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)
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.
5 secondary outcomes
Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention
Time frame: one year
Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms
Time frame: one year
Percent Reduction in Shocks Delivered Per Patient for Treating FVT
Time frame: one year
Compare Likelihood of Syncopal Events Associated With FVT
Time frame: one year
Evaluate Different Possible Predictors of ATP Success
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 11 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17169131Lunati M, Defaye P, Mermi J, Garcia-Alberola A, Merino JL, Arenal A, Cappato R, Navarro X, Passardi M, Santini M. Improvement of quality of life by means of antitachy pacing: from PainFREE to the ADVANCE-D Trial. Pacing Clin Electrophysiol. 2006 Dec;29 Suppl 2:S35-9. doi: 10.1111/j.1540-8159.2006.00488.x.
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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 Lunati, Dr. principal investigator
Ospedale Niguarda Cà Granda - Milano
Riccardo Cappato, Dr. principal investigator
Istituto Policlinico S. Donato Milanese
Massimo Santini, Prof. principal investigator
San Filippo Neri - Roma
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 2 inclusion and 11 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 11 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 12 May 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 to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) (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 NCT00147277, which also lists 1 linked publication.
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 11 Jul 2025.