Observační postmarketingová studie využívající komerčně schválených zdravotnických prostředků Biosense Webster (BWI) k léčbě účastníků se srdeční arytmií (SECURE)
Observační postmarketingová studie pro hodnocení průběžné bezpečnosti a účinnosti katetrizačního mapování a ablace za použití komerčně schválených zdravotnických prostředků BWI pro léčbu pacientů se srdečními arytmiemi
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Nathalie Macours
- Telefonní číslo: +32 479 97 05 05
- E-mail: nmacours1@its.jnj.com
Studijní záloha kontaktů
- Jméno: Liesbeth Gorissen
- E-mail: LGORISSE@ITS.JNJ.com
Studijní místa
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Aalst, Belgie, 9300
- Nábor
- OLV Aalst
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Bruges, Belgie, 8000
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- AZ Sint-Jan Brugge
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Brussels, Belgie, 1000
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- CHU Saint-Pierre
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Edegem, Belgie, 2650
- Nábor
- UZ Antwerp
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Ghent, Belgie, 9000
- Nábor
- Maria Middelares
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Hasselt, Belgie, 3500
- Nábor
- Jessa Hospital
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Jette, Belgie, 1090
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- UZ Brussels
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La Louvière, Belgie, 7100
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- ASBL CHU HELORA Hôpital de La Louvière site Jolimont
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Aarhus, Dánsko, 8200
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- Aarhus University Hospital
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Copenhagen, Dánsko, 2100
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- Rigshospitalet
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Clermont-Ferrand, Francie, 63000
- Nábor
- CHU de Clermont-Ferrand
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Lyon, Francie, 69002
- Nábor
- Les Hospices Civils de Lyon
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Marseille, Francie, 13285
- Nábor
- Hôpital Saint Joseph de Marseille
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Paris, Francie, 75674
- Nábor
- Institut Mutualiste Montsouris
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Rennes, Francie, 35033
- Nábor
- CHU de Rennes
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Strasbourg, Francie, 67000
- Nábor
- Les Hôpitaux Universitaires de Strasbourg
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Talence, Francie, 33404
- Nábor
- Centre Hospitalier Universitaire de Bordeaux
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Maastricht, Holandsko, 6229 EV
- Nábor
- Clinical Trial Center Maastricht
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Rotterdam, Holandsko, 3015 GD
- Nábor
- Erasmus University Medical Center
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Dublin, Irsko, D07 WKW8
- Nábor
- Mater Private Heart and Vascular Centre
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Acquaviva delle Fonti, Itálie, 70021
- Nábor
- Ospedale Generale Regionale "F. Miulli"
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Ancona, Itálie, 60126
- Nábor
- A.O. Universitaria Delle Marche
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Milan, Itálie, 20097
- Nábor
- IRCCS Policlinico San Donato
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Naples, Itálie, 80122
- Nábor
- Clinica Mediterranea
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Jerusalem, Izrael, 9103102
- Nábor
- Shaare Zedek Medical Center
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Tel Aviv, Izrael, 6423906
- Dokončeno
- Tel Aviv Sourasky Medical Center
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Budapest, Maďarsko, H-1085
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- Semmelweis University
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Bergen, Norsko, 5021
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- Haukeland University Hospital
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Bad Neustadt an der Saale, Německo, 97616
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- Rhön-Klinikum Campus Bad Neustadt
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Bad Oeynhausen, Německo, 3245
- Nábor
- Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
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Bad Segeberg, Německo, 23795
- Nábor
- Segeberger Kliniken
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Bautzen, Německo, 02625
- Nábor
- Oberlausitz-Kliniken
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Essen, Německo, 45131
- Nábor
- Alfried Krupp Hospital
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Frankfurt, Německo, 60431
- Dokončeno
- Cardioangiologisches Centrum Bethanien (CCB)
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Giessen, Německo, 35390
- Nábor
- Justus-Liebig-University Giessen
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Hamburg, Německo, 22763
- Nábor
- Asklepios Klinik Altona
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Munich, Německo, 80636
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- German Heart Centre Munich
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Carnaxide, Portugalsko, 2790-134
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- Hospital de Santa Cruz
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Graz, Rakousko, 8010
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- Medical University of Graz
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Linz, Rakousko, 4020
- Nábor
- Ordensklinikum Linz GMBH
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Wiener Neustadt, Rakousko, 2700
- Nábor
- Universitätsklinikum Wiener Neustadt
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Leicester, Spojené království, LE3 9QP
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- Glenfield Hospital
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London, Spojené království, SW3 6NP
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- Royal Brompton Hospital
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London, Spojené království, SW17 0QT
- Nábor
- St George's Hospital
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London, Spojené království, EC1A 7BE
- Dokončeno
- St. Bartholomew's Hospital
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Gothenburg, Švédsko, 413 45
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- Sahlgrenska University Hospital
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Bern, Švýcarsko, 03010
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- INSELSPITAL Universitätsspital Bern
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
Časové okno: 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
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Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
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AF: Number of Participants with Repeated Ablation
Časové okno: 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)
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AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection
Časové okno: 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)
|
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SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT
Časové okno: 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
Časové okno: 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
Časové okno: From Day 1 to Day 365
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Up to Day 365
|
Number of participants with heart failure hospitalization will be reported. |
Up to Day 365
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BWI_2019_05
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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