Clinical trial NCT04750798: An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrhythmias
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-11
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 7 Days
measure: AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
timeFrame: Up to 7 Days
measure: 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
timeFrame: Up to 7 Days
measure: SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
timeFrame: Up to 7 Days
measure: SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway
timeFrame: Up to 7 Days
measure: VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure
timeFrame: Up to 7 days
measure: VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT
timeFrame: Up to 7 days
measure: VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
timeFrame: Up to 7 days
Secondary outcomes:
measure: Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
timeFrame: Up to 365 Days
measure: Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])
timeFrame: Up to 365 Days
measure: AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)
timeFrame: Up to 7 Days
measure: SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
timeFrame: Up to 7 Days
measure: SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction
timeFrame: Up to 7 Days
measure: VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure
timeFrame: Up to 7 Days
measure: 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
timeFrame: Up to 7 Days
measure: AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes
timeFrame: From Day 91 to Day 365 (post-blanking)
measure: AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes
timeFrame: From Day 91 to Day 365 (post-blanking)
measure: AF: Number of Participants with Repeated Ablation
timeFrame: From Day 91 to Day 365 (post-blanking)
measure: AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection
timeFrame: From Day 91 to Day 365 (post-blanking)
measure: AF: Change in AF Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device
timeFrame: Baseline, Day 91 up to Day 365
measure: SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT
timeFrame: From Day 1 to Day 365
measure: SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure
timeFrame: From Day 1 to Day 365
measure: SVT: Number of Participants with Repeated Ablation
timeFrame: From Day 1 to Day 365
measure: SVT: Change in Study Arrhythmia Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device
timeFrame: From Day 1 to Day 365
measure: VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT
timeFrame: From Day 1 to Day 365
measure: VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure
timeFrame: From Day 1 to Day 365
measure: VT: Number of Participants with Repeated Ablation
timeFrame: From Day 1 to Day 365
measure: VT: Number of Participants with All Cause and Cardiac Mortality
timeFrame: Up to Day 365
measure: VT: Number of Participants with Heart Failure Hospitalization
timeFrame: Up to Day 365
measure: VT (For Participants with Continuous Arrhythmia Monitoring): Number of Participants with PVC Burden
timeFrame: Up to Day 365
measure: VT (For Participants with Implantable Arrhythmia Monitoring): Number of Participants with VT Burden
timeFrame: Up to Day 365
Other outcomes:
measure: VARIPURE sub-study: Assessment of Learning Curve
timeFrame: Up to Day 365
measure: VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
timeFrame: Up to Day 365
measure: VARIPURE sub-study: Number of Participants With Vagal Response During Ablation
timeFrame: Up to Day 365
measure: VARIPURE sub-study: Number of Participants With Acute Kidney Failure Post Ablation
timeFrame: Up to Day 365
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GMBH
city: Aalst
country: Belgium
facility: OLV Aalst
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Edegem
country: Belgium
facility: UZ Antwerp
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Jette
country: Belgium
facility: UZ Brussels
city: La Louvière
country: Belgium
facility: ASBL CHU HELORA Hôpital de La Louvière site Jolimont
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Lyon
country: France
facility: Les Hospices Civils de Lyon
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Talence
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Bad Neustadt an der Saale
country: Germany
facility: Rhön-Klinikum Campus Bad Neustadt
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien (CCB)
city: Munich
country: Germany
facility: German Heart Centre Munich
city: Dublin
country: Ireland
facility: Mater Private Heart and Vascular Centre
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Generale Regionale "F. Miulli"
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
city: Maastricht
country: Netherlands
facility: Clinical Trial Center Maastricht
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
city: Bern
country: Switzerland
facility: INSELSPITAL Universitätsspital Bern
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Biosense Webster, Inc.
name: Biosense Webster, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: