Um estudo observacional pós-comercialização usando dispositivos médicos Biosense Webster (BWI) comercialmente aprovados para o tratamento de participantes com arritmias cardíacas (SECURE)
Um estudo observacional pós-comercialização para avaliação da segurança e eficácia contínuas do mapeamento e ablação por cateter usando dispositivos médicos BWI aprovados comercialmente para o tratamento de pacientes com 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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Nathalie Macours
- Número de telefone: +32 479 97 05 05
- E-mail: nmacours1@its.jnj.com
Estude backup de contato
- Nome: Liesbeth Gorissen
- E-mail: LGORISSE@ITS.JNJ.com
Locais de estudo
-
-
-
Bad Neustadt an der Saale, Alemanha, 97616
- Recrutamento
- Rhön-Klinikum Campus Bad Neustadt
-
Bad Oeynhausen, Alemanha, 3245
- Recrutamento
- Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
-
Bad Segeberg, Alemanha, 23795
- Recrutamento
- Segeberger Kliniken
-
Bautzen, Alemanha, 02625
- Recrutamento
- Oberlausitz-Kliniken
-
Essen, Alemanha, 45131
- Recrutamento
- Alfried Krupp Hospital
-
Frankfurt, Alemanha, 60431
- Concluído
- Cardioangiologisches Centrum Bethanien (CCB)
-
Giessen, Alemanha, 35390
- Recrutamento
- Justus-Liebig-University Giessen
-
Hamburg, Alemanha, 22763
- Recrutamento
- Asklepios Klinik Altona
-
Munich, Alemanha, 80636
- Recrutamento
- German Heart Centre Munich
-
-
-
-
-
Aalst, Bélgica, 9300
- Recrutamento
- OLV Aalst
-
Bruges, Bélgica, 8000
- Recrutamento
- AZ Sint-Jan Brugge
-
Brussels, Bélgica, 1000
- Recrutamento
- CHU Saint-Pierre
-
Edegem, Bélgica, 2650
- Recrutamento
- UZ Antwerp
-
Ghent, Bélgica, 9000
- Recrutamento
- Maria Middelares
-
Hasselt, Bélgica, 3500
- Recrutamento
- Jessa Hospital
-
Jette, Bélgica, 1090
- Recrutamento
- UZ Brussels
-
La Louvière, Bélgica, 7100
- Recrutamento
- ASBL CHU HELORA Hôpital de La Louvière site Jolimont
-
-
-
-
-
Aarhus, Dinamarca, 8200
- Recrutamento
- Aarhus University Hospital
-
Copenhagen, Dinamarca, 2100
- Recrutamento
- Rigshospitalet
-
-
-
-
-
Clermont-Ferrand, França, 63000
- Recrutamento
- CHU de Clermont-Ferrand
-
Lyon, França, 69002
- Recrutamento
- Les Hospices Civils de Lyon
-
Marseille, França, 13285
- Recrutamento
- Hôpital Saint Joseph de Marseille
-
Paris, França, 75674
- Recrutamento
- Institut Mutualiste Montsouris
-
Rennes, França, 35033
- Recrutamento
- CHU de Rennes
-
Strasbourg, França, 67000
- Recrutamento
- Les Hôpitaux Universitaires de Strasbourg
-
Talence, França, 33404
- Recrutamento
- Centre Hospitalier Universitaire de Bordeaux
-
-
-
-
-
Maastricht, Holanda, 6229 EV
- Recrutamento
- Clinical Trial Center Maastricht
-
Rotterdam, Holanda, 3015 GD
- Recrutamento
- Erasmus University Medical Center
-
-
-
-
-
Budapest, Hungria, H-1085
- Recrutamento
- Semmelweis University
-
-
-
-
-
Dublin, Irlanda, D07 WKW8
- Recrutamento
- Mater Private Heart and Vascular Centre
-
-
-
-
-
Jerusalem, Israel, 9103102
- Recrutamento
- Shaare Zedek Medical Center
-
Tel Aviv, Israel, 6423906
- Concluído
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Acquaviva delle Fonti, Itália, 70021
- Recrutamento
- Ospedale Generale Regionale "F. Miulli"
-
Ancona, Itália, 60126
- Recrutamento
- A.O. Universitaria Delle Marche
-
Milan, Itália, 20097
- Recrutamento
- IRCCS Policlinico San Donato
-
Naples, Itália, 80122
- Recrutamento
- Clinica Mediterranea
-
-
-
-
-
Bergen, Noruega, 5021
- Recrutamento
- Haukeland University Hospital
-
-
-
-
-
Carnaxide, Portugal, 2790-134
- Recrutamento
- Hospital de Santa Cruz
-
-
-
-
-
Leicester, Reino Unido, LE3 9QP
- Recrutamento
- Glenfield Hospital
-
London, Reino Unido, SW3 6NP
- Recrutamento
- Royal Brompton Hospital
-
London, Reino Unido, SW17 0QT
- Recrutamento
- St George's Hospital
-
London, Reino Unido, EC1A 7BE
- Concluído
- St. Bartholomew's Hospital
-
-
-
-
-
Gothenburg, Suécia, 413 45
- Recrutamento
- Sahlgrenska University Hospital
-
-
-
-
-
Bern, Suíça, 03010
- Recrutamento
- INSELSPITAL Universitätsspital Bern
-
-
-
-
-
Graz, Áustria, 8010
- Recrutamento
- Medical University of Graz
-
Linz, Áustria, 4020
- Recrutamento
- Ordensklinikum Linz GMBH
-
Wiener Neustadt, Áustria, 2700
- Recrutamento
- Universitätsklinikum Wiener Neustadt
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: Up to 7 Days
|
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
|
|
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
Prazo: Up to 7 Days
|
Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported. |
Up to 7 Days
|
|
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
Prazo: Up to 7 Days
|
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
|
|
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
Prazo: 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
|
|
SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway
Prazo: 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
|
|
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure
Prazo: 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
|
|
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT
Prazo: Up to 7 days
|
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
|
|
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
Prazo: Up to 7 days
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
Prazo: Up to 365 Days
|
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
|
|
Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])
Prazo: Up to 365 Days
|
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
|
|
AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)
Prazo: Up to 7 Days
|
Number of participants with Acute reconnection among all targeted PVs will be reported. |
Up to 7 Days
|
|
SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
Prazo: Up to 7 Days
|
Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported. |
Up to 7 Days
|
|
SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction
Prazo: Up to 7 Days
|
Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported. |
Up to 7 Days
|
|
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure
Prazo: Up to 7 Days
|
Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported. |
Up to 7 Days
|
|
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
Prazo: Up to 7 Days
|
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
|
|
AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes
Prazo: From Day 91 to Day 365 (post-blanking)
|
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)
|
|
AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes
Prazo: From Day 91 to Day 365 (post-blanking)
|
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)
|
|
AF: Number of Participants with Repeated Ablation
Prazo: From Day 91 to Day 365 (post-blanking)
|
Number of participants with repeated ablation post-blanking will be reported. |
From Day 91 to Day 365 (post-blanking)
|
|
AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection
Prazo: From Day 91 to Day 365 (post-blanking)
|
Number of participants with repeated ablation with PV reconnection post blanking will be reported. |
From Day 91 to Day 365 (post-blanking)
|
|
SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to Day 365
|
Number of participants with all cause and cardiac mortality will be reported. |
Up to Day 365
|
|
VT: Number of Participants with Heart Failure Hospitalization
Prazo: Up to Day 365
|
Number of participants with heart failure hospitalization will be reported. |
Up to Day 365
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
- Diretor de estudo: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BWI_2019_05
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .