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NCT Number: NCT04750798

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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BWI Medical Device

Device

Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.

VARIPULSE Catheter

Device

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.

Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. SVT: Number of Participants with Repeated Ablation

    Time frame: From Day 1 to Day 365

    Number of participants with repeated ablation will be reported.

  15. 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.

  16. 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.

  17. VT: Number of Participants with Repeated Ablation

    Time frame: From Day 1 to Day 365

    Number of participants with repeated ablation will be reported.

  18. 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.

  19. VT: Number of Participants with Heart Failure Hospitalization

    Time frame: Up to Day 365

    Number of participants with heart failure hospitalization will be reported.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liesbeth Gorissen

CONTACT

[email protected]

Nathalie Macours

CONTACT

[email protected]

+32 479 97 05 05

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study 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

Acronym: SECURE

Important dates

Study start
2021
Primary completion
2036
Study completion
2037
First posted
Feb 11, 2021
Registry last updated
Jul 6, 2026

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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