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| ID | Type | Description | Link |
|---|---|---|---|
| ADVANCE III |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long NID | Experimental | Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia |
|
| Short NID | Active Comparator | Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Defibrillator | Device | Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to study completion or exit whichever occured first |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorg O. Schwab, MD | University of Bonn, Bonn, Germany | Study Chair |
| Maurizio Gasparini, MD | Humanitas Hospital, Milano Italy | Principal Investigator |
| Maurizio Lunati, MD | Niguarda Hospital, Milano, Italy | Principal Investigator |
| Bernd Lemke, MD | Klinikum Lüdenscheid, Lüdenscheid, Germany | Principal Investigator |
| João Sousa, MD | H. Santa Maria - Lisbon - Portugal | Principal Investigator |
| Andrzej Okreglicki, MD | University of Cape Town, Cape Town, South Africa | Principal Investigator |
| Angel Arenal, MD | Hospital Gregorio Marañón, Madrid, Spain | Principal Investigator |
| Maurits Wijffels, MD | St. Antonius hospital - NIEUWEGEIN, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital St-Joseph | Gilly | Belgium | ||||
| CHU Brugmann |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34392257 | Derived | 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. | |
| 31826936 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short NID | Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia |
| FG001 | Long NID | Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Implantable Defibrillator | Device | number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia |
|
| Laken |
| Belgium |
| CHR La Citadelle Liege | Liège | Belgium |
| CHR Namur | Namur | Belgium |
| AZ Nikolaas | Sint-Niklaas | Belgium |
| KAS Gentofte | Hellerup | Denmark |
| Odense Universitets Hospital | Odense | Denmark |
| Turku University Central Hospital | Turku | Finland |
| Hôpital Michalon- CHU Grenoble | Grenoble | France |
| CHU Nantes - Hôpital Guillaume et René Laënnec | Nantes | France |
| NCN Nantes | Nantes | France |
| Hopital de la Pitie Salpetriere | Paris | France |
| Centre Hospitalier de Pau | Pau | France |
| CHU Hôpital de Pontchaillou Rennes | Rennes | France |
| CH Rangueil Toulouse | Toulouse | France |
| Clinique Pasteur | Toulouse | France |
| RWTH Aachen | Aachen | Germany |
| University of Bonn | Bonn | Germany |
| Kardiologisches Zentrum an der Klinik Rotes Kreuz | Frankfurt am Main | Germany |
| SRH Wald-Klinikum Gera gGmbH | Gera | Germany |
| Universitätskliniken des Saarlandes | Homburg | Germany |
| Klinikum Lüdenscheid | Lüdenscheid | Germany |
| Klinikum Dorothea Christiane Erxleben Quedlinburg | Quedlinburg | Germany |
| Universität Rostock- Medizinische Fakultät | Rostock | Germany |
| Diakoniekrankenhaus Rotenburg | Rotenburg (Wümme) | Germany |
| Semmelweis University AOK | Budapest | Hungary |
| Zala County Hospital | Zalaegerszeg | Hungary |
| Presidio Ospedaliero di Venere | Carbonara | Bari | Italy |
| Azienda.Ospedaliera.G.M. Lancisi | Ancona | Italy |
| Azienda Ospedaliera G. Rummo | Benevento | Italy |
| Cliniche Gavazzeni | Bergamo | Italy |
| Stab. Ospedaliero Di Summa-Perrino - Brindisi | Brindisi | Italy |
| Casa di Cura Mater Domini | Castellanza | Italy |
| Ospedale Pugliese e Ciaccio | Catanzaro | Italy |
| A.O. Santa Croce e Carle | Cuneo | Italy |
| Ente Ospedaliero Ospedali Galliera - Genova | Genova | Italy |
| Ospedale Maggiore di Lodi | Lodi | Italy |
| Istituto Ca' Granda-Niguarda | Milan | Italy |
| San Carlo Borromeo | Milan | Italy |
| Nuovo Osp. Civile S. Agostino | Modena | Italy |
| P.O. di Montebelluna | Montebelluna | Italy |
| Ospedale S. Giacomo | Novi Ligure | Italy |
| Policlinico S. Matteo | Pavia | Italy |
| Osp. S. Maria degli Angeli - Pordenone | Pordenone | Italy |
| Ospedale Misericordia e Dolce | Prato | Italy |
| Azienda Complesso Ospedaliero San Filippo Neri | Roma | Italy |
| Ospedale Sandro Pertini | Roma | Italy |
| Ospedale Sant Eugenio | Roma | Italy |
| Istituto Clinico Humanitas | Rozzano | Italy |
| Osp. S. Giovanni di Dio e Ruggi dAragona | Salerno | Italy |
| AZ. Osp. Ordine Mauriziano | Torino | Italy |
| A.O. S.Maria della Misericordia | Udine | Italy |
| ULSS N.6 S. Bortolo - Vicenza | Vicenza | Italy |
| Medisch Spectrum Twente | Enschede | Netherlands |
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | Netherlands |
| Zoz Mswia | Bialystok | Poland |
| Hospital Garcia Orta, SA | Almada | Portugal |
| Hospital de Santa Maria | Lisbon | Portugal |
| Hospital de Santa Marta | Lisbon | Portugal |
| Hospital Geral de Santo António | Porto | Portugal |
| Tyumen Cardiology Center | Tyumen | Russia |
| King Fahd Armed Forces Hospital | Jeddah | Saudi Arabia |
| King Khalid Univ. Hospital - King Saud University | Riyadh | Saudi Arabia |
| Bloemfontein Medi-Clinic | Bloemfontein | South Africa |
| Christiaan Barnard Memorial Hospital | Cape Town | South Africa |
| University of Cape Town - Groote Schuur Hospital | Cape Town | South Africa |
| Vincent Pallotti Hospital | Cape Town | South Africa |
| Milpark Hospital | Johannesburg | South Africa |
| Sunninghill Hospital | Johannesburg | South Africa |
| UNITAS Hospital | Pretoria | South Africa |
| Hospital General Universitario de Alicante | Alicante | Spain |
| Hospital de Basurto - Bilbao | Bilbao | Spain |
| Hospital General Yagüe | Burgos | Spain |
| Hospital General San Pedro de Alcantara | Cáceres | Spain |
| Hospital General de Ciudad Real | Ciudad Real | Spain |
| Hospital de Donostia | Donostia / San Sebastian | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | Spain |
| H. Ramón y Cajal | Madrid | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| Hospital Puerta de Hierro Majadahonda | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Clinico de Malaga - Virgen de la Victoria | Málaga | Spain |
| Hospital Universitario Son Dureta | Palma Mallorca | Spain |
| Hospital Universitario de San Juan | Sant Joan d'Alacant | Spain |
| Hospital Ntra. Sra. de la Candelaria | Santa Cruz de Tenerife | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Spain |
| Hospital Virgen de La Salud | Toledo | Spain |
| Hospital Arnau de Vilanova | Valencia | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | Spain |
| Chuvi-Xeral-Cíes | Vigo | Spain |
| Hospital de Txagorritxu | Vitoria-Gasteiz | Spain |
| Derived |
| Gasparini 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. |
| 29759624 | Derived | Gasparini 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. |
| 29251799 | Derived | 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. |
| 24838360 | Derived | Kloppe 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. |
| 23652522 | Derived | Gasparini 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. |
| 19175450 | Derived | Schwab 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Short NID | Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia |
| BG001 | Long NID | Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For the primary endpoint analysis, only patients with at least a device data record were considered. | Posted | Number | 95% Confidence Interval | rate of therapies per 100 patient-years | From enrollment to study completion or exit whichever occured first |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | end of study | Participants |
Adverse events collection started at day 0 after enrollment until study completion or exit whichever occured first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short NID | Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia | 300 | 954 | 0 | 954 | ||
| EG001 | Long NID | Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia | 258 | 948 | 0 | 948 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic Events | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lead Dislodgment | Cardiac disorders | Systematic Assessment |
| ||
| Worsening heart failure | Cardiac disorders | Systematic Assessment |
| ||
| System Dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Inappropriate Tachyarrhythmia Therapy | Cardiac disorders | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Pocket Hematoma | Surgical and medical procedures | Systematic Assessment |
| ||
| Post Surgical Infection | Surgical and medical procedures | Systematic Assessment |
| ||
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Elevated Threshold | Cardiac disorders | Systematic Assessment |
| ||
| All cause syncope | Cardiac disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| epicardial LV implant | Surgical and medical procedures | Systematic Assessment |
| ||
| Pericardial Effusion | Surgical and medical procedures | Systematic Assessment |
| ||
| Atrial Arrhthmias | Cardiac disorders | Systematic Assessment |
| ||
| Pocket Infection | Surgical and medical procedures | Systematic Assessment |
| ||
| Angina | Cardiac disorders | Systematic Assessment |
| ||
| Extracardiac Stimulation | Cardiac disorders | Systematic Assessment |
| ||
| Pneumothorax | Surgical and medical procedures | Systematic Assessment |
| ||
| Dyspnea | Cardiac disorders | Systematic Assessment |
| ||
| Neoplasia | General disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Device migration | Surgical and medical procedures | Systematic Assessment |
| ||
| hypotension | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Musculoskeletal diseases | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Manotta | MEDTRONIC Clinical Research Institute | +39022413.1 | laura.manotta@medtronic.com |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D012769 | Shock |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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| >=65 years |
|
| Male |
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| Spain |
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| Italy |
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| Hungary |
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| Netherlands |
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| Belgium |
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| France |
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| Russian Federation |
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| Saudi Arabia |
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| Denmark |
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| Finland |
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| South Africa |
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| Poland |
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| Portugal |
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