An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
- Conditions
- Cardiac Arrhythmias
- Registration Number
- NCT04750798
- Lead Sponsor
- Biosense Webster, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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.
SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway Up to 7 Days Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs) 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.
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 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.
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins Up to 7 Days Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line 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.
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure 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.
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT 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.
- Secondary Outcome Measures
Name Time Method VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure 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.
VT: Number of Participants with Repeated Ablation From Day 1 to Day 365 Number of participants with repeated ablation will be reported.
VT: Number of Participants with All Cause and Cardiac Mortality Up to Day 365 Number of participants with all cause and cardiac mortality will be reported.
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure Up to 7 Days Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported.
SVT: Number of Participants with Repeated Ablation From Day 1 to Day 365 Number of participants with repeated ablation will be reported.
VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT 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.
AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs) Up to 7 Days Number of participants with Acute reconnection among all targeted PVs will be reported.
AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes 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.
SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT From Day 1 to Day 365 Number of participants with freedom from documented arrhythmia of the primary SVT (episodes \>=30 seconds) will be reported.
SVT: Change in Study Arrhythmia Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device From Day 1 to Day 365 Study arrhythmia burden will be measured as the change in the percentage of time that participants will be in study arrhythmia (symptomatic and asymptomatic) compared to baseline will be calculated. The change in study arrhythmia for the overall study population will be calculated and expressed.
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs]) 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.
Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs]) 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.
SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure Up to 7 Days Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported.
AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes 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.
AF: Change in AF Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device Baseline, Day 91 up to Day 365 AF burden will be measured as the change in the percentage of time that participants will be in AF (symptomatic and asymptomatic) compared to baseline will be calculated. The change in AF burden for the overall study population will be calculated and expressed.
SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure 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.
AF: Number of Participants with Repeated Ablation From Day 91 to Day 365 (post-blanking) Number of participants with repeated ablation post-blanking will be reported.
AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection From Day 91 to Day 365 (post-blanking) Number of participants with repeated ablation with PV reconnection post blanking will be reported.
SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction Up to 7 Days Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported.
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 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.
VT: Number of Participants with Heart Failure Hospitalization Up to Day 365 Number of participants with heart failure hospitalization will be reported.
VT (For Participants with Continuous Arrhythmia Monitoring): Number of Participants with PVC Burden Up to Day 365 Number of participants with PVC burden for participants with continuous arrhythmia monitoring will be reported based on criterias such as % PVC beats/total beats and at least 80% reduction in PVC burden.
VT (For Participants with Implantable Arrhythmia Monitoring): Number of Participants with VT Burden Up to Day 365 Number of participants with VT burden for participants with implantable arrhythmia monitoring will be reported based on criterias such as implantable cardioverter defibrillator (ICD) shocks (appropriate and inappropriate), appropriate antitachycardia pacing therapy (ATP), VT episodes and at least 75% reduction in VT burden.
Trial Locations
- Locations (32)
Medical University of Graz
🇦🇹Graz, Austria
Ordensklinikum Linz GMBH
🇦🇹Linz, Austria
OLV Aalst
🇧🇪Aalst, Belgium
AZ Sint-Jan Brugge
🇧🇪Brugge, Belgium
CHU Saint-Pierre
🇧🇪Brussels, Belgium
UZ Antwerp
🇧🇪Edegem, Belgium
Jessa Hospital
🇧🇪Hasselt, Belgium
UZ Brussels
🇧🇪Jette, Belgium
ASBL CHU HELORA Hôpital de La Louvière site Jolimont
🇧🇪La Louvière, Belgium
Aarhus University Hospital
🇩🇰Aarhus, Denmark
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