Une étude observationnelle post-commercialisation utilisant des dispositifs médicaux Biosense Webster (BWI) approuvés commercialement pour le traitement des participants souffrant d'arythmies cardiaques (SECURE)
Une étude observationnelle post-commercialisation pour l'évaluation de l'innocuité et de l'efficacité continues de la cartographie par cathéter et de l'ablation à l'aide de dispositifs médicaux BWI commercialement approuvés pour le traitement des patients souffrant d'arythmies cardiaques
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nathalie Macours
- Numéro de téléphone: +32 479 97 05 05
- E-mail: nmacours1@its.jnj.com
Sauvegarde des contacts de l'étude
- Nom: Liesbeth Gorissen
- E-mail: LGORISSE@ITS.JNJ.com
Lieux d'étude
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Bad Neustadt an der Saale, Allemagne, 97616
- Recrutement
- Rhön-Klinikum Campus Bad Neustadt
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Bad Oeynhausen, Allemagne, 3245
- Recrutement
- Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
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Bad Segeberg, Allemagne, 23795
- Recrutement
- Segeberger Kliniken
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Bautzen, Allemagne, 02625
- Recrutement
- Oberlausitz-Kliniken
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Essen, Allemagne, 45131
- Recrutement
- Alfried Krupp Hospital
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Frankfurt, Allemagne, 60431
- Complété
- Cardioangiologisches Centrum Bethanien (CCB)
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Giessen, Allemagne, 35390
- Recrutement
- Justus-Liebig-University Giessen
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Hamburg, Allemagne, 22763
- Recrutement
- Asklepios Klinik Altona
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Munich, Allemagne, 80636
- Recrutement
- German Heart Centre Munich
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Aalst, Belgique, 9300
- Recrutement
- OLV Aalst
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Bruges, Belgique, 8000
- Recrutement
- AZ Sint-Jan Brugge
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Brussels, Belgique, 1000
- Recrutement
- CHU Saint-Pierre
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Edegem, Belgique, 2650
- Recrutement
- UZ Antwerp
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Ghent, Belgique, 9000
- Recrutement
- Maria Middelares
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Hasselt, Belgique, 3500
- Recrutement
- Jessa Hospital
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Jette, Belgique, 1090
- Recrutement
- UZ Brussels
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La Louvière, Belgique, 7100
- Recrutement
- ASBL CHU HELORA Hôpital de La Louvière site Jolimont
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Aarhus, Danemark, 8200
- Recrutement
- Aarhus University Hospital
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Copenhagen, Danemark, 2100
- Recrutement
- Rigshospitalet
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Clermont-Ferrand, France, 63000
- Recrutement
- CHU de Clermont-Ferrand
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Lyon, France, 69002
- Recrutement
- Les Hospices Civils de Lyon
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Marseille, France, 13285
- Recrutement
- Hôpital Saint Joseph de Marseille
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Paris, France, 75674
- Recrutement
- Institut Mutualiste Montsouris
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Rennes, France, 35033
- Recrutement
- CHU de Rennes
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Strasbourg, France, 67000
- Recrutement
- Les Hôpitaux Universitaires de Strasbourg
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Talence, France, 33404
- Recrutement
- Centre Hospitalier Universitaire de Bordeaux
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Budapest, Hongrie, H-1085
- Recrutement
- Semmelweis University
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Dublin, Irlande, D07 WKW8
- Recrutement
- Mater Private Heart and Vascular Centre
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Jerusalem, Israël, 9103102
- Recrutement
- Shaare Zedek Medical Center
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Tel Aviv, Israël, 6423906
- Complété
- Tel Aviv Sourasky Medical Center
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Acquaviva delle Fonti, Italie, 70021
- Recrutement
- Ospedale Generale Regionale "F. Miulli"
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Ancona, Italie, 60126
- Recrutement
- A.O. Universitaria Delle Marche
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Milan, Italie, 20097
- Recrutement
- IRCCS Policlinico San Donato
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Naples, Italie, 80122
- Recrutement
- Clinica Mediterranea
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Graz, L'Autriche, 8010
- Recrutement
- Medical University of Graz
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Linz, L'Autriche, 4020
- Recrutement
- Ordensklinikum Linz GMBH
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Wiener Neustadt, L'Autriche, 2700
- Recrutement
- Universitätsklinikum Wiener Neustadt
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Carnaxide, Le Portugal, 2790-134
- Recrutement
- Hospital de Santa Cruz
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Bergen, Norvège, 5021
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- Haukeland University Hospital
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Maastricht, Pays-Bas, 6229 EV
- Recrutement
- Clinical Trial Center Maastricht
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Rotterdam, Pays-Bas, 3015 GD
- Recrutement
- Erasmus University Medical Center
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Leicester, Royaume-Uni, LE3 9QP
- Recrutement
- Glenfield Hospital
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London, Royaume-Uni, SW3 6NP
- Recrutement
- Royal Brompton Hospital
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London, Royaume-Uni, SW17 0QT
- Recrutement
- St George's Hospital
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London, Royaume-Uni, EC1A 7BE
- Complété
- St. Bartholomew's Hospital
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Bern, Suisse, 03010
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- INSELSPITAL Universitätsspital Bern
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Gothenburg, Suède, 413 45
- Recrutement
- Sahlgrenska University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
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AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
Délai: 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
Délai: 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
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SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
Délai: 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])
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure
Délai: 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
Délai: 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
Délai: 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
Délai: Up to Day 365
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Number of participants with heart failure hospitalization will be reported. |
Up to Day 365
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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DUACURE Sub-Study: Number of Participants With Vagal Response During Ablation
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BWI_2019_05
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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