Eine Post-Marketing-Beobachtungsstudie mit kommerziell zugelassenen Medizinprodukten von Biosense Webster (BWI) zur Behandlung von Teilnehmern mit Herzrhythmusstörungen (SECURE)
Eine Post-Marketing-Beobachtungsstudie zur Bewertung der laufenden Sicherheit und Wirksamkeit von Katheter-Mapping und -Ablation unter Verwendung von kommerziell zugelassenen BWI-Medizinprodukten zur Behandlung von Patienten mit Herzrhythmusstörungen
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Nathalie Macours
- Telefonnummer: +32 479 97 05 05
- E-Mail: nmacours1@its.jnj.com
Studieren Sie die Kontaktsicherung
- Name: Liesbeth Gorissen
- E-Mail: LGORISSE@ITS.JNJ.com
Studienorte
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Aalst, Belgien, 9300
- Rekrutierung
- OLV Aalst
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Bruges, Belgien, 8000
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- AZ Sint-Jan Brugge
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Brussels, Belgien, 1000
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- CHU Saint-Pierre
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Edegem, Belgien, 2650
- Rekrutierung
- UZ Antwerp
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Ghent, Belgien, 9000
- Rekrutierung
- Maria Middelares
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Hasselt, Belgien, 3500
- Rekrutierung
- Jessa Hospital
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Jette, Belgien, 1090
- Rekrutierung
- UZ Brussels
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La Louvière, Belgien, 7100
- Rekrutierung
- ASBL CHU HELORA Hôpital de La Louvière site Jolimont
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Bad Neustadt an der Saale, Deutschland, 97616
- Rekrutierung
- Rhön-Klinikum Campus Bad Neustadt
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Bad Oeynhausen, Deutschland, 3245
- Rekrutierung
- Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
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Bad Segeberg, Deutschland, 23795
- Rekrutierung
- Segeberger Kliniken
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Bautzen, Deutschland, 02625
- Rekrutierung
- Oberlausitz-Kliniken
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Essen, Deutschland, 45131
- Rekrutierung
- Alfried Krupp Hospital
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Frankfurt, Deutschland, 60431
- Abgeschlossen
- Cardioangiologisches Centrum Bethanien (CCB)
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Giessen, Deutschland, 35390
- Rekrutierung
- Justus-Liebig-University Giessen
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Hamburg, Deutschland, 22763
- Rekrutierung
- Asklepios Klinik Altona
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Munich, Deutschland, 80636
- Rekrutierung
- German Heart Centre Munich
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Aarhus, Dänemark, 8200
- Rekrutierung
- Aarhus University Hospital
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Copenhagen, Dänemark, 2100
- Rekrutierung
- Rigshospitalet
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Clermont-Ferrand, Frankreich, 63000
- Rekrutierung
- CHU de Clermont-Ferrand
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Lyon, Frankreich, 69002
- Rekrutierung
- Les Hospices Civils de Lyon
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Marseille, Frankreich, 13285
- Rekrutierung
- Hôpital Saint Joseph de Marseille
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Paris, Frankreich, 75674
- Rekrutierung
- Institut Mutualiste Montsouris
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Rennes, Frankreich, 35033
- Rekrutierung
- CHU de Rennes
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Strasbourg, Frankreich, 67000
- Rekrutierung
- Les Hôpitaux Universitaires de Strasbourg
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Talence, Frankreich, 33404
- Rekrutierung
- Centre Hospitalier Universitaire de Bordeaux
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Dublin, Irland, D07 WKW8
- Rekrutierung
- Mater Private Heart and Vascular Centre
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Jerusalem, Israel, 9103102
- Rekrutierung
- Shaare Zedek Medical Center
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Tel Aviv, Israel, 6423906
- Abgeschlossen
- Tel Aviv Sourasky Medical Center
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Acquaviva delle Fonti, Italien, 70021
- Rekrutierung
- Ospedale Generale Regionale "F. Miulli"
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Ancona, Italien, 60126
- Rekrutierung
- A.O. Universitaria Delle Marche
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Milan, Italien, 20097
- Rekrutierung
- IRCCS Policlinico San Donato
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Naples, Italien, 80122
- Rekrutierung
- Clinica Mediterranea
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Maastricht, Niederlande, 6229 EV
- Rekrutierung
- Clinical Trial Center Maastricht
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Rotterdam, Niederlande, 3015 GD
- Rekrutierung
- Erasmus University Medical Center
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Bergen, Norwegen, 5021
- Rekrutierung
- Haukeland University Hospital
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Carnaxide, Portugal, 2790-134
- Rekrutierung
- Hospital de Santa Cruz
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Gothenburg, Schweden, 413 45
- Rekrutierung
- Sahlgrenska University Hospital
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Bern, Schweiz, 03010
- Rekrutierung
- INSELSPITAL Universitätsspital Bern
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Budapest, Ungarn, H-1085
- Rekrutierung
- Semmelweis University
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Leicester, Vereinigtes Königreich, LE3 9QP
- Rekrutierung
- Glenfield Hospital
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London, Vereinigtes Königreich, SW3 6NP
- Rekrutierung
- Royal Brompton Hospital
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London, Vereinigtes Königreich, SW17 0QT
- Rekrutierung
- St George's Hospital
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London, Vereinigtes Königreich, EC1A 7BE
- Abgeschlossen
- St. Bartholomew's Hospital
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Graz, Österreich, 8010
- Rekrutierung
- Medical University of Graz
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Linz, Österreich, 4020
- Rekrutierung
- Ordensklinikum Linz GMBH
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Wiener Neustadt, Österreich, 2700
- Rekrutierung
- Universitätsklinikum Wiener Neustadt
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: 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
Zeitfenster: Up to 7 Days
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
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|
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure
Zeitfenster: 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
Zeitfenster: 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
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|
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
Zeitfenster: 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])
Zeitfenster: 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
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AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
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AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes
Zeitfenster: 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)
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AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Day 365
|
Number of participants with heart failure hospitalization will be reported. |
Up to Day 365
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BWI_2019_05
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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