Un estudio observacional posterior a la comercialización que utiliza dispositivos médicos Biosense Webster (BWI) aprobados comercialmente para el tratamiento de participantes con arritmias cardíacas (SECURE)
Un estudio observacional posterior a la comercialización para la evaluación de la seguridad y la eficacia continuas del mapeo y la ablación del catéter utilizando dispositivos médicos BWI aprobados comercialmente para el tratamiento de pacientes con arritmias cardíacas
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nathalie Macours
- Número de teléfono: +32 479 97 05 05
- Correo electrónico: nmacours1@its.jnj.com
Copia de seguridad de contactos de estudio
- Nombre: Liesbeth Gorissen
- Correo electrónico: LGORISSE@ITS.JNJ.com
Ubicaciones de estudio
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Bad Neustadt an der Saale, Alemania, 97616
- Reclutamiento
- Rhön-Klinikum Campus Bad Neustadt
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Bad Oeynhausen, Alemania, 3245
- Reclutamiento
- Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
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Bad Segeberg, Alemania, 23795
- Reclutamiento
- Segeberger Kliniken
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Bautzen, Alemania, 02625
- Reclutamiento
- Oberlausitz-Kliniken
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Essen, Alemania, 45131
- Reclutamiento
- Alfried Krupp Hospital
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Frankfurt, Alemania, 60431
- Terminado
- Cardioangiologisches Centrum Bethanien (CCB)
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Giessen, Alemania, 35390
- Reclutamiento
- Justus-Liebig-University Giessen
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Hamburg, Alemania, 22763
- Reclutamiento
- Asklepios Klinik Altona
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Munich, Alemania, 80636
- Reclutamiento
- German Heart Centre Munich
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Graz, Austria, 8010
- Reclutamiento
- Medical University of Graz
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Linz, Austria, 4020
- Reclutamiento
- Ordensklinikum Linz GMBH
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Wiener Neustadt, Austria, 2700
- Reclutamiento
- Universitätsklinikum Wiener Neustadt
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Aalst, Bélgica, 9300
- Reclutamiento
- OLV Aalst
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Bruges, Bélgica, 8000
- Reclutamiento
- AZ Sint-Jan Brugge
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Brussels, Bélgica, 1000
- Reclutamiento
- CHU Saint-Pierre
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Edegem, Bélgica, 2650
- Reclutamiento
- UZ Antwerp
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Ghent, Bélgica, 9000
- Reclutamiento
- Maria Middelares
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Hasselt, Bélgica, 3500
- Reclutamiento
- Jessa Hospital
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Jette, Bélgica, 1090
- Reclutamiento
- UZ Brussels
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La Louvière, Bélgica, 7100
- Reclutamiento
- ASBL CHU HELORA Hôpital de La Louvière site Jolimont
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Aarhus, Dinamarca, 8200
- Reclutamiento
- Aarhus University Hospital
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Copenhagen, Dinamarca, 2100
- Reclutamiento
- Rigshospitalet
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Clermont-Ferrand, Francia, 63000
- Reclutamiento
- CHU de Clermont-Ferrand
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Lyon, Francia, 69002
- Reclutamiento
- Les Hospices Civils de Lyon
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Marseille, Francia, 13285
- Reclutamiento
- Hôpital Saint Joseph de Marseille
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Paris, Francia, 75674
- Reclutamiento
- Institut Mutualiste Montsouris
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Rennes, Francia, 35033
- Reclutamiento
- CHU de Rennes
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Strasbourg, Francia, 67000
- Reclutamiento
- Les Hôpitaux Universitaires de Strasbourg
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Talence, Francia, 33404
- Reclutamiento
- Centre Hospitalier Universitaire de Bordeaux
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Budapest, Hungría, H-1085
- Reclutamiento
- Semmelweis University
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Dublin, Irlanda, D07 WKW8
- Reclutamiento
- Mater Private Heart and Vascular Centre
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Jerusalem, Israel, 9103102
- Reclutamiento
- Shaare Zedek Medical Center
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Tel Aviv, Israel, 6423906
- Terminado
- Tel Aviv Sourasky Medical Center
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Acquaviva delle Fonti, Italia, 70021
- Reclutamiento
- Ospedale Generale Regionale "F. Miulli"
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Ancona, Italia, 60126
- Reclutamiento
- A.O. Universitaria Delle Marche
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Milan, Italia, 20097
- Reclutamiento
- IRCCS Policlinico San Donato
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Naples, Italia, 80122
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- Clinica Mediterranea
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Bergen, Noruega, 5021
- Reclutamiento
- Haukeland University Hospital
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Maastricht, Países Bajos, 6229 EV
- Reclutamiento
- Clinical Trial Center Maastricht
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Rotterdam, Países Bajos, 3015 GD
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- Erasmus University Medical Center
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Carnaxide, Portugal, 2790-134
- Reclutamiento
- Hospital de Santa Cruz
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Leicester, Reino Unido, LE3 9QP
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- Glenfield Hospital
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London, Reino Unido, SW3 6NP
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- Royal Brompton Hospital
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London, Reino Unido, SW17 0QT
- Reclutamiento
- St George's Hospital
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London, Reino Unido, EC1A 7BE
- Terminado
- St. Bartholomew's Hospital
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Gothenburg, Suecia, 413 45
- Reclutamiento
- Sahlgrenska University Hospital
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Bern, Suiza, 03010
- Reclutamiento
- INSELSPITAL Universitätsspital Bern
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to 7 Days
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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
Periodo de tiempo: Up to 7 Days
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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
Periodo de tiempo: Up to 7 days
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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
Periodo de tiempo: 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)
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
Periodo de tiempo: 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])
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From Day 1 to Day 365
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Number of participants with freedom from documented arrhythmia of the primary SVT (episodes >=30 seconds) will be reported. |
From Day 1 to Day 365
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SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure
Periodo de tiempo: From Day 1 to Day 365
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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
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SVT: Number of Participants with Repeated Ablation
Periodo de tiempo: From Day 1 to Day 365
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Number of participants with repeated ablation will be reported. |
From Day 1 to Day 365
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VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT
Periodo de tiempo: From Day 1 to Day 365
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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
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VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure
Periodo de tiempo: From Day 1 to Day 365
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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
|
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VT: Number of Participants with Repeated Ablation
Periodo de tiempo: From Day 1 to Day 365
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Number of participants with repeated ablation will be reported. |
From Day 1 to Day 365
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VT: Number of Participants with All Cause and Cardiac Mortality
Periodo de tiempo: Up to Day 365
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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
Periodo de tiempo: Up to Day 365
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Number of participants with heart failure hospitalization will be reported. |
Up to Day 365
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
Periodo de tiempo: Up to Day 365
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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DUACURE Sub-Study: Number of Participants With Coronary Spasm During Ablation
Periodo de tiempo: Up to Day 365
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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
|
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DUACURE Sub-Study: Number of Participants With Vagal Response During Ablation
Periodo de tiempo: Up to Day 365
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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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BWI_2019_05
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .