BWI Medical Device
DeviceParticipants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.
NCT Number: NCT04750798
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.
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Observational
Medical University of Graz, Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Up to 7 Days
Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 Days
Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 Days
Number of participants with Acute reconnection among all targeted PVs will be reported.
Time frame: Up to 7 Days
Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported.
Time frame: Up to 7 Days
Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported.
Time frame: Up to 7 Days
Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 91 to Day 365 (post-blanking)
Number of participants with repeated ablation post-blanking will be reported.
Time frame: From Day 91 to Day 365 (post-blanking)
Number of participants with repeated ablation with PV reconnection post blanking will be reported.
Time frame: From Day 1 to Day 365
Number of participants with freedom from documented arrhythmia of the primary SVT (episodes >=30 seconds) will be reported.
Time frame: 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.
Time frame: From Day 1 to Day 365
Number of participants with repeated ablation will be reported.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to Day 365
Number of participants with repeated ablation will be reported.
Time frame: Up to Day 365
Number of participants with all cause and cardiac mortality will be reported.
Time frame: Up to Day 365
Number of participants with heart failure hospitalization will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Liesbeth Gorissen
CONTACT
Nathalie Macours
CONTACT
Biosense Webster, Inc.
Industry
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
Acronym: SECURE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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