Heart DiseasePhase 4ADVANCEIIINCT00617175
Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
A Phase 4 study testing Implantable Defibrillator in people with Heart Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 91 sites in 14 countries.
Trial summary
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- Implantable Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,902 participants
- Where
- 91 sitesin 14 countries
- Study dates
- Mar 2008to Feb 2012
- 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
- Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines.
- Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.
Who cannot join
- ICD replacements and upgrading.
- Brugada Syndrome, Long QT and HCM patients
- Ventricular tachyarrhythmia associated with reversible cause.
- Other electrical implantable devices (Neurostimulators, etc.).
- Subject's life expectancy less than 1 year.
- Subject on heart transplant list which is expected in less than 1 year.
Show all 12Show fewer
- Subject is <18 years of age, or the subject is under a minimum age that is required as defined by local law
- Women who are pregnant or women of childbearing potential who are not on a reliable form of birth control.
- Unwillingness or inability to provide written informed consent.
- Enrolment in, or intention to participate in, another clinical trial.
- Inaccessibility to come to the study center for the follow-up visits.
- Mechanical tricuspid valve.
Trial locations and contacts
91 sites in 14 countries.
91 sites in 14 countries
Italy26 sites
Azienda.Ospedaliera.G.M. Lancisi
Ancona
Azienda Ospedaliera G. Rummo
Benevento
Cliniche Gavazzeni
Bergamo
Stab. Ospedaliero Di Summa-Perrino - Brindisi
Brindisi
Presidio Ospedaliero di Venere
Carbonara, Bari
Casa di Cura Mater Domini
Castellanza
Ospedale Pugliese e Ciaccio
Catanzaro
A.O. Santa Croce e Carle
Cuneo
Ente Ospedaliero Ospedali Galliera - Genova
Genova
Ospedale Maggiore di Lodi
Lodi
Istituto Ca' Granda-Niguarda
Milan
San Carlo Borromeo
Milan
Nuovo Osp. Civile S. Agostino
Modena
P.O. di Montebelluna
Montebelluna
Ospedale S. Giacomo
Novi Ligure
Policlinico S. Matteo
Pavia
Osp. S. Maria degli Angeli - Pordenone
Pordenone
Ospedale Misericordia e Dolce
Prato
Azienda Complesso Ospedaliero San Filippo Neri
Roma
Ospedale Sandro Pertini
Roma
Ospedale Sant Eugenio
Roma
Istituto Clinico Humanitas
Rozzano
Osp. S. Giovanni di Dio e Ruggi dAragona
Salerno
AZ. Osp. Ordine Mauriziano
Torino
A.O. S.Maria della Misericordia
Udine
ULSS N.6 S. Bortolo - Vicenza
Vicenza
Spain21 sites
Hospital General Universitario de Alicante
Alicante
Hospital de Basurto - Bilbao
Bilbao
Hospital General Yagüe
Burgos
Hospital General San Pedro de Alcantara
Cáceres
Hospital General de Ciudad Real
Ciudad Real
Hospital de Donostia
Donostia / San Sebastian
Hospital Universitario Virgen de las Nieves
Granada
H. Ramón y Cajal
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Puerta de Hierro Majadahonda
Madrid
Hospital Universitario La Paz
Madrid
Hospital Clinico de Malaga - Virgen de la Victoria
Málaga
Hospital Universitario Son Dureta
Palma Mallorca
Hospital Universitario de San Juan
Sant Joan d'Alacant
Hospital Ntra. Sra. de la Candelaria
Santa Cruz de Tenerife
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital Virgen de La Salud
Toledo
Hospital Arnau de Vilanova
Valencia
Hospital Clinico Universitario de Valencia
Valencia
Chuvi-Xeral-Cíes
Vigo
Hospital de Txagorritxu
Vitoria-Gasteiz
Germany9 sites
RWTH Aachen
Aachen
University of Bonn
Bonn
Kardiologisches Zentrum an der Klinik Rotes Kreuz
Frankfurt am Main
SRH Wald-Klinikum Gera gGmbH
Gera
Universitätskliniken des Saarlandes
Homburg
Klinikum Lüdenscheid
Lüdenscheid
Klinikum Dorothea Christiane Erxleben Quedlinburg
Quedlinburg
Universität Rostock- Medizinische Fakultät
Rostock
Diakoniekrankenhaus Rotenburg
Rotenburg (Wümme)
France8 sites
Hôpital Michalon- CHU Grenoble
Grenoble
CHU Nantes - Hôpital Guillaume et René Laënnec
Nantes
NCN Nantes
Nantes
Hopital de la Pitie Salpetriere
Paris
Centre Hospitalier de Pau
Pau
CHU Hôpital de Pontchaillou Rennes
Rennes
CH Rangueil Toulouse
Toulouse
Clinique Pasteur
Toulouse
South Africa7 sites
Bloemfontein Medi-Clinic
Bloemfontein
Christiaan Barnard Memorial Hospital
Cape Town
University of Cape Town - Groote Schuur Hospital
Cape Town
Vincent Pallotti Hospital
Cape Town
Milpark Hospital
Johannesburg
Sunninghill Hospital
Johannesburg
UNITAS Hospital
Pretoria
Belgium5 sites
Hopital St-Joseph
Gilly
CHU Brugmann
Laken
CHR La Citadelle Liege
Liège
CHR Namur
Namur
AZ Nikolaas
Sint-Niklaas
Portugal4 sites
Hospital Garcia Orta, SA
Almada
Hospital de Santa Maria
Lisbon
Hospital de Santa Marta
Lisbon
Hospital Geral de Santo António
Porto
Hungary2 sites
Semmelweis University AOK
Budapest
Zala County Hospital
Zalaegerszeg
Netherlands2 sites
Medisch Spectrum Twente
Enschede
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein
Saudi Arabia2 sites
King Fahd Armed Forces Hospital
Jeddah
King Khalid Univ. Hospital - King Saud University
Riyadh
About this study
Official title: ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.
Read the detailed description
Primary Objective:
The primary objective is to demonstrate a 20% reduction of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (NID) compared to a NID of 18 out of 24 in subjects with either Class I or IIA indication for ICD implantation, regardless of cardiac resynchronization capabilities.
Secondary Objectives:
- Evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (CL ≤ 320 ms) and for spontaneous ventricular episodes.
- Evaluate the efficacy of ATP in successfully treating spontaneous ventricular episodes (CL: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study.
- Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms.
- Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms).
- Describe the economic impact and the quality of life consequences.
- Conditions
- Heart Disease
- Being tested
- Implantable Defibrillator
- Keywords
- Implantable Cardiac Defibrillator, therapies reduction, Shocks, Quality of Life
- Medical subject headings
- Heart Diseases, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable DefibrillatorDevice
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
Implantable DefibrillatorDevice
number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia
| Study group | Role | What they receive |
|---|---|---|
| Long NID | Experimental | Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia Receives: Device: Implantable Defibrillator |
| Short NID | Active comparator | Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia Receives: Device: Implantable Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.
for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed.
The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times * 100.
Measured: From enrollment to study completion or exit whichever occured first
Secondary outcomes (1)
Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2011
- Study completionFeb 2012
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 (7)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies 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
- 1,902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorg O. Schwab, MD, Study chair, University of Bonn, Bonn, GermanyMaurizio Gasparini, MD, Principal investigator, Humanitas Hospital, Milano ItalyMaurizio Lunati, MD, Principal investigator, Niguarda Hospital, Milano, ItalyBernd Lemke, MD, Principal investigator, Klinikum Lüdenscheid, Lüdenscheid, GermanyJoão Sousa, MD, Principal investigator, H. Santa Maria - Lisbon - PortugalAndrzej Okreglicki, MD, Principal investigator, University of Cape TownAngel Arenal, MD, Principal investigator, Hospital Gregorio Marañón, Madrid, SpainMaurits Wijffels, MD, Principal investigator, St. Antonius hospital - NIEUWEGEIN, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617175
- Sponsor's protocol ID
- ADVANCE III
- Other IDs
- ADVANCE III
- Acronym
- ADVANCEIII
- Status last verified
- Jun 2025
- First submitted
- 4 Feb 2008
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34392257Gasparini M, Kloppe A, Lunati M, Varma N, Martinez-Ferrer JB, Hersi A, Gulaj M, Wijffels MCEF, Arenal A, Mangoni di Santo Stefano L, Proclemer A. Sex differences in implantable cardiac defibrillator therapy according to arrhythmia detection times. Heart. 2020 Apr;106(7):520-526. doi: 10.1136/heartjnl-2019-315650. Epub 2019 Dec 11.
PubMed 31826936Gasparini M, Lunati MG, Proclemer A, Arenal A, Kloppe A, Martinez Ferrer JB, Hersi AS, Gulaj M, Wijffels MCE, Santi E, Manotta L, Varma N. Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial. JACC Clin Electrophysiol. 2017 Nov;3(11):1275-1282. doi: 10.1016/j.jacep.2017.05.001. Epub 2017 May 31.
PubMed 29759624Gasparini 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 29251799Kloppe A, Proclemer A, Arenal A, Lunati M, Martinez Ferrer JB, Hersi A, Gulaj M, Wijffels MC, Santi E, Manotta L, Mangoni L, Gasparini M. Efficacy of long detection interval implantable cardioverter-defibrillator settings in secondary prevention population: data from the Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) trial. Circulation. 2014 Jul 22;130(4):308-14. doi: 10.1161/CIRCULATIONAHA.114.009468. Epub 2014 May 16.
PubMed 24838360Gasparini M, Proclemer A, Klersy C, Kloppe A, Lunati M, Ferrer JB, Hersi A, Gulaj M, Wijfels MC, Santi E, Manotta L, Arenal A. Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial. JAMA. 2013 May 8;309(18):1903-11. doi: 10.1001/jama.2013.4598.
PubMed 23652522Schwab JO, Gasparini M, Lunati M, Proclemer A, Kaup B, Santi E, Ligorio G, Klersy C, DE Sousa J, Okreglicki A, Arenal A, Wijffels M, Lemke B. Avoid delivering therapies for nonsustained fast ventricular tachyarrhythmia in patients with implantable cardioverter/defibrillator: the ADVANCE III Trial. J Cardiovasc Electrophysiol. 2009 Jun;20(6):663-6. doi: 10.1111/j.1540-8167.2008.01415.x. Epub 2009 Jan 9.
PubMed 19175450
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 III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
- ClinicalTrials.gov ID
- NCT00617175
- Acronym / sponsor ID
- ADVANCEIII / ADVANCE III
- Conditions
- Heart Disease
- Keywords
- Implantable Cardiac Defibrillator, therapies reduction, Shocks, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,902 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 25 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.
Detailed description
Primary Objective:
The primary objective is to demonstrate a 20% reduction of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (NID) compared to a NID of 18 out of 24 in subjects with either Class I or IIA indication for ICD implantation, regardless of cardiac resynchronization capabilities.
Secondary Objectives:
- Evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (CL ≤ 320 ms) and for spontaneous ventricular episodes.
- Evaluate the efficacy of ATP in successfully treating spontaneous ventricular episodes (CL: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study.
- Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms.
- Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms).
- Describe the economic impact and the quality of life consequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long NID | Experimental | Device: Implantable DefibrillatorProgramming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia |
| Short NID | Active comparator | Device: Implantable DefibrillatorProgramming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines.
- Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.
Key exclusion criteria (12 listed)
- ICD replacements and upgrading.
- Brugada Syndrome, Long QT and HCM patients
- Ventricular tachyarrhythmia associated with reversible cause.
- Other electrical implantable devices (Neurostimulators, etc.).
- Subject's life expectancy less than 1 year.
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 DefibrillatorNumber of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia | Device | Long NID |
| Implantable Defibrillatornumber of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia | Device | Short NID |
Primary outcome
For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.
Time frame: From enrollment to study completion or exit whichever occured first
for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed. The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times * 100.
1 secondary outcome
Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.
Time frame: end of study
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.
- 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 31826936Gasparini M, Kloppe A, Lunati M, Varma N, Martinez-Ferrer JB, Hersi A, Gulaj M, Wijffels MCEF, Arenal A, Mangoni di Santo Stefano L, Proclemer A. Sex differences in implantable cardiac defibrillator therapy according to arrhythmia detection times. Heart. 2020 Apr;106(7):520-526. doi: 10.1136/heartjnl-2019-315650. Epub 2019 Dec 11.
- Derived from this study: PubMed 29759624Gasparini M, Lunati MG, Proclemer A, Arenal A, Kloppe A, Martinez Ferrer JB, Hersi AS, Gulaj M, Wijffels MCE, Santi E, Manotta L, Varma N. Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial. JACC Clin Electrophysiol. 2017 Nov;3(11):1275-1282. doi: 10.1016/j.jacep.2017.05.001. Epub 2017 May 31.
- 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 24838360Kloppe A, Proclemer A, Arenal A, Lunati M, Martinez Ferrer JB, Hersi A, Gulaj M, Wijffels MC, Santi E, Manotta L, Mangoni L, Gasparini M. Efficacy of long detection interval implantable cardioverter-defibrillator settings in secondary prevention population: data from the Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) trial. Circulation. 2014 Jul 22;130(4):308-14. doi: 10.1161/CIRCULATIONAHA.114.009468. Epub 2014 May 16.
- Derived from this study: PubMed 23652522Gasparini M, Proclemer A, Klersy C, Kloppe A, Lunati M, Ferrer JB, Hersi A, Gulaj M, Wijfels MC, Santi E, Manotta L, Arenal A. Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial. JAMA. 2013 May 8;309(18):1903-11. doi: 10.1001/jama.2013.4598.
- Derived from this study: PubMed 19175450Schwab JO, Gasparini M, Lunati M, Proclemer A, Kaup B, Santi E, Ligorio G, Klersy C, DE Sousa J, Okreglicki A, Arenal A, Wijffels M, Lemke B. Avoid delivering therapies for nonsustained fast ventricular tachyarrhythmia in patients with implantable cardioverter/defibrillator: the ADVANCE III Trial. J Cardiovasc Electrophysiol. 2009 Jun;20(6):663-6. doi: 10.1111/j.1540-8167.2008.01415.x. Epub 2009 Jan 9.
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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.
Jorg O. Schwab, MD study chair
University of Bonn, Bonn, Germany
Maurizio Gasparini, MD principal investigator
Humanitas Hospital, Milano Italy
Maurizio Lunati, MD principal investigator
Niguarda Hospital, Milano, Italy
91 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantable Defibrillator in people with Heart Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 91 sites in 14 countries.
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 12 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 91 sites in Italy, Spain, Germany, France, South Africa and 9 more countries. 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 25 Feb 2013). 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?
For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured. (time frame: From enrollment to study completion or exit whichever occured first). 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 NCT00617175, which also lists 7 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.