Обсервационное постмаркетинговое исследование с использованием коммерчески одобренных медицинских устройств Biosense Webster (BWI) для лечения участников с сердечными аритмиями (SECURE)
Обсервационное постмаркетинговое исследование для оценки текущей безопасности и эффективности катетерного картирования и абляции с использованием коммерчески одобренных медицинских устройств BWI для лечения пациентов с сердечными аритмиями
The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Nathalie Macours
- Номер телефона: +32 479 97 05 05
- Электронная почта: nmacours1@its.jnj.com
Учебное резервное копирование контактов
- Имя: Liesbeth Gorissen
- Электронная почта: LGORISSE@ITS.JNJ.com
Места учебы
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Graz, Австрия, 8010
- Рекрутинг
- Medical University of Graz
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Linz, Австрия, 4020
- Рекрутинг
- Ordensklinikum Linz GMBH
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Wiener Neustadt, Австрия, 2700
- Рекрутинг
- Universitätsklinikum Wiener Neustadt
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Aalst, Бельгия, 9300
- Рекрутинг
- OLV Aalst
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Bruges, Бельгия, 8000
- Рекрутинг
- AZ Sint-Jan Brugge
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Brussels, Бельгия, 1000
- Рекрутинг
- CHU Saint-Pierre
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Edegem, Бельгия, 2650
- Рекрутинг
- UZ Antwerp
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Ghent, Бельгия, 9000
- Рекрутинг
- Maria Middelares
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Hasselt, Бельгия, 3500
- Рекрутинг
- Jessa Hospital
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Jette, Бельгия, 1090
- Рекрутинг
- UZ Brussels
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La Louvière, Бельгия, 7100
- Рекрутинг
- ASBL CHU HELORA Hôpital de La Louvière site Jolimont
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Budapest, Венгрия, H-1085
- Рекрутинг
- Semmelweis University
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Bad Neustadt an der Saale, Германия, 97616
- Рекрутинг
- Rhön-Klinikum Campus Bad Neustadt
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Bad Oeynhausen, Германия, 3245
- Рекрутинг
- Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
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Bad Segeberg, Германия, 23795
- Рекрутинг
- Segeberger Kliniken
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Bautzen, Германия, 02625
- Рекрутинг
- Oberlausitz-Kliniken
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Essen, Германия, 45131
- Рекрутинг
- Alfried Krupp Hospital
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Frankfurt, Германия, 60431
- Завершенный
- Cardioangiologisches Centrum Bethanien (CCB)
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Giessen, Германия, 35390
- Рекрутинг
- Justus-Liebig-University Giessen
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Hamburg, Германия, 22763
- Рекрутинг
- Asklepios Klinik Altona
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Munich, Германия, 80636
- Рекрутинг
- German Heart Centre Munich
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Aarhus, Дания, 8200
- Рекрутинг
- Aarhus University Hospital
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Copenhagen, Дания, 2100
- Рекрутинг
- Rigshospitalet
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Jerusalem, Израиль, 9103102
- Рекрутинг
- Shaare Zedek Medical Center
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Tel Aviv, Израиль, 6423906
- Завершенный
- Tel Aviv Sourasky Medical Center
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Dublin, Ирландия, D07 WKW8
- Рекрутинг
- Mater Private Heart and Vascular Centre
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Acquaviva delle Fonti, Италия, 70021
- Рекрутинг
- Ospedale Generale Regionale "F. Miulli"
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Ancona, Италия, 60126
- Рекрутинг
- A.O. Universitaria Delle Marche
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Milan, Италия, 20097
- Рекрутинг
- IRCCS Policlinico San Donato
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Naples, Италия, 80122
- Рекрутинг
- Clinica Mediterranea
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Maastricht, Нидерланды, 6229 EV
- Рекрутинг
- Clinical Trial Center Maastricht
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Rotterdam, Нидерланды, 3015 GD
- Рекрутинг
- Erasmus University Medical Center
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Bergen, Норвегия, 5021
- Рекрутинг
- Haukeland University Hospital
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Carnaxide, Португалия, 2790-134
- Рекрутинг
- Hospital de Santa Cruz
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Leicester, Соединенное Королевство, LE3 9QP
- Рекрутинг
- Glenfield Hospital
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London, Соединенное Королевство, SW3 6NP
- Рекрутинг
- Royal Brompton Hospital
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London, Соединенное Королевство, SW17 0QT
- Рекрутинг
- St George's Hospital
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London, Соединенное Королевство, EC1A 7BE
- Завершенный
- St. Bartholomew's Hospital
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Clermont-Ferrand, Франция, 63000
- Рекрутинг
- CHU de Clermont-Ferrand
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Lyon, Франция, 69002
- Рекрутинг
- Les Hospices Civils de Lyon
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Marseille, Франция, 13285
- Рекрутинг
- Hôpital Saint Joseph de Marseille
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Paris, Франция, 75674
- Рекрутинг
- Institut Mutualiste Montsouris
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Rennes, Франция, 35033
- Рекрутинг
- CHU de Rennes
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Strasbourg, Франция, 67000
- Рекрутинг
- Les Hôpitaux Universitaires de Strasbourg
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Talence, Франция, 33404
- Рекрутинг
- Centre Hospitalier Universitaire de Bordeaux
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Bern, Швейцария, 03010
- Рекрутинг
- INSELSPITAL Universitätsspital Bern
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Gothenburg, Швеция, 413 45
- Рекрутинг
- Sahlgrenska University Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Study population consists of participants diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined Biosense Webster Inc (BWI) therapeutic catheter.
Описание
Inclusion criteria
- Diagnosed with paroxysmal or persistent Atrial Fibrillation (AF) or supraventricular tachycardia (SVT) or ventricular tachycardia (VT) and scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined BW therapeutic catheter
- Able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care
- Signed patient informed consent form (ICF) as applicable per local regulation
Exclusion criteria:
- Currently participating in an interventional (drug, device, biologic) clinical trial
- Life expectancy of less than 12-months
- Presenting any contraindication for the use of BWI commercially approved medical devices, as indicated in the respective user manuals
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Participants Diagnosed with Cardiac Arrhythmias
Patients diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure in routine clinical practice for management of their arrhythmia with a BWI therapeutic catheter/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed. |
Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study. Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study. Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants with Primary Adverse Events (PAEs) Related to Device in Scope and/or Study Procedure Within 7 Days of the Initial Study Procedure
Временное ограничение: Up to 7 Days
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PAEs in participants with Atrial Fibrillation (AF) and for SupraVentricular Tachycardia (SVT) includes device or procedure related death, atrio-esophageal fistula/ esophageal perforation , severe pulmonary vein stenosis, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block; PAEs in participants with Ventricular Tachycardia (VT) includes device or procedure related death, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block, aggravation or new onset heart failure, coronary artery injury, aortic dissection and valve injury. |
Up to 7 Days
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AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
Временное ограничение: Up to 7 Days
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Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported. |
Up to 7 Days
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SVT (Sinus Nodal Re-entrant Tachycardia, Focal AT, Multifocal AT, AVNRT, Non Re-entrant Junctional Tachycardias): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
Временное ограничение: Up to 7 Days
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Number of participants with sinus nodal re-entrant tachycardia, focal atrial tachycardia (AT) multifocal AT, atrioventricular nodal reentry tachycardia (AVNRT), non re-entrant junctional tachycardias with non-inducibility of the targeted tachycardia at end of procedure will be reported. |
Up to 7 Days
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SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
Временное ограничение: Up to 7 Days
|
Number of participants with Macro Re-entrant Atrial Tachycardia (MRAT) with complete bidirectional conduction block across the ablation line will be reported. |
Up to 7 Days
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SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway
Временное ограничение: Up to 7 Days
|
Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported. |
Up to 7 Days
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VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure
Временное ограничение: Up to 7 days
|
Number of participants with non-inducibility of the targeted ischemic or non-ischemic VT at end of procedure will be reported. |
Up to 7 days
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VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT
Временное ограничение: Up to 7 days
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Number of participants with elimination of clinically relevant idiopathic VT will be reported. Clinically relevant: any spontaneous VT or any induced VT. |
Up to 7 days
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VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
Временное ограничение: Up to 7 days
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Number of participants with elimination of clinically relevant idiopathic PVCs will be reported. Clinically relevant: any spontaneous PVC or any induced PVC; prior to treatment, PVCs would be deemed clinically relevant if they are present greater than (>) 20 percent (%) of daily heartbeat. |
Up to 7 days
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
Временное ограничение: Up to 365 Days
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Number of participants with device and/or procedure-related Serious Adverse Events (SADEs) within 7 days (early-onset), >7-30 days (peri-procedural) and >30 days (late onset) following the initial study procedure will be reported. |
Up to 365 Days
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Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])
Временное ограничение: Up to 365 Days
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Number of participants with device and/or procedure-related non-serious adverse events (Non-serious ADEs) within 7 days (early-onset), >7-30 days (peri-procedural) and >30 days (Late Onset) following the initial study procedure will be reported. |
Up to 365 Days
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AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)
Временное ограничение: Up to 7 Days
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Number of participants with Acute reconnection among all targeted PVs will be reported. |
Up to 7 Days
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SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
Временное ограничение: Up to 7 Days
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Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported. |
Up to 7 Days
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SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction
Временное ограничение: Up to 7 Days
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Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported. |
Up to 7 Days
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VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure
Временное ограничение: Up to 7 Days
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Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported. |
Up to 7 Days
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VT (Ischemic or Non-ischemic): Number of Participants with Elimination of all Targeted Late Potentials and Local Abnormal Ventricular Activation (LAVAs) at end of Procedure
Временное ограничение: Up to 7 Days
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Number of participants with elimination of all targeted late potentials and local abnormal ventricular activation (LAVAs) at end of procedure will be reported. |
Up to 7 Days
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AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes
Временное ограничение: From Day 91 to Day 365 (post-blanking)
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Number of participants with freedom from documented (symptomatic and asymptomatic) AF, AT, AFL episodes (episodes greater than or equal to [>=] 30 seconds) post-blanking will be reported. |
From Day 91 to Day 365 (post-blanking)
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AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes
Временное ограничение: From Day 91 to Day 365 (post-blanking)
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Number of participants with freedom from documented symptomatic AF, AT, AFL episodes (episodes >= 30 seconds) post-blanking will be reported. |
From Day 91 to Day 365 (post-blanking)
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AF: Number of Participants with Repeated Ablation
Временное ограничение: From Day 91 to Day 365 (post-blanking)
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Number of participants with repeated ablation post-blanking will be reported. |
From Day 91 to Day 365 (post-blanking)
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AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection
Временное ограничение: From Day 91 to Day 365 (post-blanking)
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Number of participants with repeated ablation with PV reconnection post blanking will be reported. |
From Day 91 to Day 365 (post-blanking)
|
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SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT
Временное ограничение: From Day 1 to Day 365
|
Number of participants with freedom from documented arrhythmia of the primary SVT (episodes >=30 seconds) will be reported. |
From Day 1 to Day 365
|
|
SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure
Временное ограничение: From Day 1 to Day 365
|
Number of participants with freedom from documented arrhythmia of new SVT, not targeted during index procedure will be reported. |
From Day 1 to Day 365
|
|
SVT: Number of Participants with Repeated Ablation
Временное ограничение: From Day 1 to Day 365
|
Number of participants with repeated ablation will be reported. |
From Day 1 to Day 365
|
|
VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT
Временное ограничение: From Day 1 to Day 365
|
Number of participants with freedom from documented arrhythmia of the clinically relevant /targeted VT (episodes >=30 seconds) will be reported. |
From Day 1 to Day 365
|
|
VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure
Временное ограничение: From Day 1 to Day 365
|
Number of participants with freedom from documented arrhythmia of new VT, not targeted during index procedure will be reported. |
From Day 1 to Day 365
|
|
VT: Number of Participants with Repeated Ablation
Временное ограничение: From Day 1 to Day 365
|
Number of participants with repeated ablation will be reported. |
From Day 1 to Day 365
|
|
VT: Number of Participants with All Cause and Cardiac Mortality
Временное ограничение: Up to Day 365
|
Number of participants with all cause and cardiac mortality will be reported. |
Up to Day 365
|
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VT: Number of Participants with Heart Failure Hospitalization
Временное ограничение: Up to Day 365
|
Number of participants with heart failure hospitalization will be reported. |
Up to Day 365
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
Временное ограничение: Up to Day 365
|
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported. |
Up to Day 365
|
|
VARIPURE Sub-Study: Number of Participants With Vagal Response During Ablation
Временное ограничение: Up to Day 365
|
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported. |
Up to Day 365
|
|
VARIPURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
Временное ограничение: Up to Day 365
|
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported. |
Up to Day 365
|
|
DUACURE Sub-Study: Number of Participants With Coronary Spasm During Ablation
Временное ограничение: Up to Day 365
|
Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported. |
Up to Day 365
|
|
DUACURE Sub-Study: Number of Participants With Vagal Response During Ablation
Временное ограничение: Up to Day 365
|
Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported. |
Up to Day 365
|
|
DUACURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
Временное ограничение: Up to Day 365
|
Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported. |
Up to Day 365
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BWI_2019_05
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .