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

June 4, 2026 updated by: Biosense Webster, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Recruiting
        • Medical University of Graz
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH
      • Sankt Pölten, Austria, 3100
        • Recruiting
        • NÖ Landesgesundheitsagentur
  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • OLV Aalst
      • Bruges, Belgium, 8000
        • Recruiting
        • AZ Sint-Jan Brugge
      • Brussels, Belgium, 1000
        • Recruiting
        • CHU Saint-Pierre
      • Edegem, Belgium, 2650
        • Recruiting
        • UZ Antwerp
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Hospital
      • Jette, Belgium, 1090
        • Recruiting
        • UZ Brussels
      • La Louvière, Belgium, 7100
        • Recruiting
        • ASBL CHU HELORA Hôpital de La Louvière site Jolimont
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
  • France
      • Lyon, France, 69002
        • Recruiting
        • Les Hospices Civils de Lyon
      • Marseille, France, 13285
        • Recruiting
        • Hôpital Saint Joseph de Marseille
      • Paris, France, 75674
        • Recruiting
        • Institut Mutualiste Montsouris
      • Talence, France, 33404
        • Recruiting
        • Centre Hospitalier Universitaire de Bordeaux
  • Germany
      • Bad Neustadt an der Saale, Germany, 97616
        • Recruiting
        • Rhön-Klinikum Campus Bad Neustadt
      • Bad Oeynhausen, Germany, 3245
        • Recruiting
        • Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
      • Bad Segeberg, Germany, 23795
        • Recruiting
        • Segeberger Kliniken
      • Essen, Germany, 45131
        • Recruiting
        • Alfried Krupp Hospital
      • Frankfurt, Germany, 60431
        • Completed
        • Cardioangiologisches Centrum Bethanien (CCB)
      • Giessen, Germany, 35390
        • Recruiting
        • Justus-Liebig-University Giessen
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona
      • Munich, Germany, 80636
        • Recruiting
        • German Heart Centre Munich
  • Hungary
      • Budapest, Hungary, H-1085
        • Recruiting
        • Semmelweis University
  • Ireland
      • Dublin, Ireland, D07 WKW8
        • Recruiting
        • Mater Private Heart and Vascular Centre
  • Israel
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Acquaviva delle Fonti, Italy, 70021
        • Recruiting
        • Ospedale Generale Regionale "F. Miulli"
      • Milan, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
      • Naples, Italy, 80122
        • Recruiting
        • Clinica Mediterranea
  • Netherlands
      • Maastricht, Netherlands, 6229 EV
        • Recruiting
        • Clinical Trial Center Maastricht
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus University Medical Center
  • Portugal
      • Carnaxide, Portugal, 2790-134
        • Recruiting
        • Hospital de Santa Cruz
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
  • Switzerland
      • Bern, Switzerland, 03010
        • Recruiting
        • Inselspital Universitatsspital Bern
  • United Kingdom
      • Leicester, United Kingdom, LE3 9QP
        • Recruiting
        • Glenfield Hospital
      • London, United Kingdom, SW3 6NP
        • Recruiting
        • Royal Brompton Hospital
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • St George's Hospital
      • London, United Kingdom, EC1A 7BE
        • Completed
        • St. Bartholomew's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
Device: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
Time Frame: Up to 7 Days
Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.
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
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.
Up to 7 Days
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
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.
Up to 7 Days
SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway
Time Frame: 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
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure
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.
Up to 7 days
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT
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.
Up to 7 days
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
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.
Up to 7 days
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
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.
Up to 7 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
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.
Up to 365 Days
Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])
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.
Up to 365 Days
AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)
Time Frame: Up to 7 Days
Number of participants with Acute reconnection among all targeted PVs will be reported.
Up to 7 Days
SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
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.
Up to 7 Days
SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction
Time Frame: Up to 7 Days
Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported.
Up to 7 Days
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure
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.
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
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.
Up to 7 Days
AF: Number of Participants with Repeated Ablation
Time Frame: 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
Time Frame: 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 Repeated Ablation
Time Frame: 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 Repeated Ablation
Time Frame: 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
Time Frame: 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
Time Frame: Up to Day 365
Number of participants with heart failure hospitalization will be reported.
Up to Day 365
AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes
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.
From Day 91 to Day 365 (post-blanking)
AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes
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.
From Day 91 to Day 365 (post-blanking)
SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT
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.
From Day 1 to Day 365
SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure
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.
From Day 1 to Day 365
VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT
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.
From Day 1 to Day 365
VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure
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.
From Day 1 to Day 365

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
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.
Up to Day 365
VARIPURE Sub-Study: Number of Participants With Vagal Response During Ablation
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.
Up to Day 365
VARIPURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
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.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Coronary Spasm During Ablation
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.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Vagal Response During Ablation
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.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
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.
Up to Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosense Webster, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BWI_2019_05 (Biosense Webster EMEA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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