An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Официальное название

An Observational Post-marketing Study for Evaluation of Ongoing Safety and Effectiveness of Catheter Mapping and Ablation Using Commercially Approved BWI Medical Devices for the Treatment of Patients With Cardiac Arrhythmias

Обзор

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.

Вмешательства

• Устройство BWI Medical Device
  Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.
• Устройство Varipulse Catheter
  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.
• Устройство Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
  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.

Первичные конечные точки

• 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 [Срок оценки: Up to 7 Days]
• AF: Number of Participants with Isolation of all Targeted Pulmonary Veins [Срок оценки: 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 [Срок оценки: Up to 7 Days]
• SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line [Срок оценки: Up to 7 Days]
• SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway [Срок оценки: Up to 7 Days]
• VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure [Срок оценки: Up to 7 days]
• VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT [Срок оценки: Up to 7 days]
• VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs) [Срок оценки: Up to 7 days]

Вторичные конечные точки (12)

• Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs]) [Срок оценки: Up to 365 Days]
• Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs]) [Срок оценки: Up to 365 Days]
• AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs) [Срок оценки: Up to 7 Days]
• SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure [Срок оценки: Up to 7 Days]
• SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction [Срок оценки: Up to 7 Days]
• VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure [Срок оценки: 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 [Срок оценки: Up to 7 Days]
• AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes [Срок оценки: From Day 91 to Day 365 (post-blanking)]
• AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes [Срок оценки: From Day 91 to Day 365 (post-blanking)]
• AF: Number of Participants with Repeated Ablation [Срок оценки: From Day 91 to Day 365 (post-blanking)]
• AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection [Срок оценки: From Day 91 to Day 365 (post-blanking)]
• SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT [Срок оценки: From Day 1 to Day 365]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 8 центров

• Rhön-Klinikum Campus Bad Neustadt — Bad Neustadt an der Saale
• Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum — Bad Oeynhausen
• Segeberger Kliniken — Bad Segeberg
• Alfried Krupp Hospital — Essen
• Cardioangiologisches Centrum Bethanien (CCB) — Frankfurt
• Justus-Liebig-University Giessen — Giessen
• Asklepios Klinik Altona — Hamburg
• German Heart Centre Munich — Munich

Бельгия · 7 центров

• OLV Aalst — Aalst
• AZ Sint-Jan Brugge — Bruges
• CHU Saint-Pierre — Brussels
• UZ Antwerp — Edegem
• Jessa Hospital — Hasselt
• UZ Brussels — Jette
• ASBL CHU HELORA Hôpital de La Louvière site Jolimont — La Louvière

Франция · 5 центров

• Les Hospices Civils de Lyon — Lyon
• Hôpital Saint Joseph de Marseille — Marseille
• Institut Mutualiste Montsouris — Paris
• Les Hôpitaux Universitaires de Strasbourg — Strasbourg
• Centre Hospitalier Universitaire de Bordeaux — Talence

Великобритания · 4 центра

• Glenfield Hospital — Leicester
• St. Bartholomew's Hospital — London
• St George's Hospital — London
• Royal Brompton Hospital — London

Австрия · 3 центра

• Medical University of Graz — Graz
• Ordensklinikum Linz GMBH — Linz
• Universitätsklinikum Wiener Neustadt — Wiener Neustadt

Италия · 3 центра

• Ospedale Generale Regionale "F. Miulli" — Acquaviva delle Fonti
• IRCCS Policlinico San Donato — Milan
• Clinica Mediterranea — Naples

Дания · 2 центра

• Aarhus University Hospital — Aarhus
• Rigshospitalet — Copenhagen

Израиль · 2 центра

• Shaare Zedek Medical Center — Jerusalem
• Tel Aviv Sourasky Medical Center — Tel Aviv

Нидерланды · 2 центра

• Clinical Trial Center Maastricht — Maastricht
• Erasmus University Medical Center — Rotterdam

Венгрия · 1 центр

• Semmelweis University — Budapest

Ирландия · 1 центр

• Mater Private Heart and Vascular Centre — Dublin

Португалия · 1 центр

• Hospital de Santa Cruz — Carnaxide

Швеция · 1 центр

• Sahlgrenska University Hospital — Gothenburg

Швейцария · 1 центр

• INSELSPITAL Universitätsspital Bern — Bern

Публикации

• Almorad A, Sebag FA, Kronborg MB, Sohns C, De Potter T, Adragao P, Bessiere F, Chierchia GB, Duytschaever M, Szeplaki G, Di Monaco A, Reichlin T, Yap SC, Wong T, Lepiece C, Linz D, Gallagher MM, Pappone C, Sommer P, Ernst S, Purerfellner H, Scherr D; VARIPURE Investigators. Pulsed field ablation with a variable loop circular catheter in atrial fibrillation: Acute outcomes from the VARIPURE multice PMID 42392466

Идентификаторы

NCT: NCT04750798 · BWI_2019_05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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