A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

Not Applicable

Completed

Conditions: Persistent Atrial Fibrillation
Premature Ventricular Complex
Paroxysmal Atrial Fibrillation
Scar-related Atrial Tachycardia
Ventricular Tachycardia

Interventions: Device: Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

Registration Number: NCT05373862

Lead Sponsor: Biosense Webster, Inc.

Brief Summary: The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Diagnosed with and candidate for clinically-indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)
At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months of enrollment
Signed participants Informed Consent Form (ICF)
Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria

Diagnosed with an arrhythmia requiring epicardial mapping
Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause
Atrial arrhythmias: participants with a left atrial size greater than (>) 55 millimeters (mm)
Left Ventricular Ejection Fraction (LVEF) less than or equal to (<=) 25 percent (%) for participants with ventricular arrhythmia
LVEF <= 40% for participants with atrial arrhythmia
Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
Contraindication to anticoagulation (that is heparin, warfarin, dabigatran)
History of blood clotting or bleeding abnormalities (example, hypercoagulable state)
Myocardial infarction within the past 2 months (60 days)
Documented thromboembolic event (including Transient Ischemic Attack [TIA]) within the past 12 months (365 days)
Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
Participants with known untreatable allergy to contrast media
Active illness or active systemic infection or sepsis
Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
Any cardiac surgery within the past 60 days (2 months) (includes Percutaneous Coronary Intervention [PCI])
Atrial septal closure within the past 6 weeks (42 days)
Presence of a condition that precludes vascular access
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
Concurrent enrollment in an investigational study evaluating another device or drug

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter	Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter	Participants with cardiac arrhythmias/ablation history who are scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures will be using multi-electrode mapping catheter.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s)	Up to 7 days of index procedure on Day 1	Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter	Up to 7 days of index procedure on Day 1	Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Secondary Outcome Measures

Name	Time	Method
Number of Responders for Physician Assessment for Maneuverability and Handling	Up to 29 weeks	Number of responders for physician assessment for maneuverability \& handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability and handling.
Number of Responders for Physician Assessment for Signal Collection and Quality	Up to 29 weeks	Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality.
Number of Responders for Physician Assessment for Workflow	Up to 29 weeks	Number of responders for physician assessment for workflow were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for workflow.
Number of Responders for Physician Assessment for Catheter Visualization	Up to 29 weeks	Number of responders for physician assessment for catheter visualization were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter visualization.
Number of Responders for Physician Assessment for Catheters Interactions	Up to 29 weeks	Number of responders for physician assessment for catheters interactions were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheters interactions.
Number of Responders for Physician Assessment for Ability to Characterize the Tissue	Up to 29 weeks	Number of responders for physician assessment for ability to characterize the tissue were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to characterize the tissue.
Number of Responders for Physician Assessment for Catheter Design	Up to 29 weeks	Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design.
Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure	Up to 7 days of index procedure on Day 1	Number of participants with SAEs excluding investigational catheter related within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Responders for Physician Assessment for Pacing	Up to 29 weeks	Number of responders for physician assessment for pacing (high output stimulation pacing and local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing.
Number of Responders for Physician Assessment for Arrhythmogenicity	Up to 29 weeks	Number of responders for physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity.
Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)	Up to 29 weeks	Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI.
Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly	Up to 29 weeks	Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to identify arrhythmia circuit or source correctly.
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter	Up to 7 days of index procedure on Day 1	Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device.

Trial Locations

Locations (4): Ospedale Generale Regionale Francesco Miulli (F. Miulli)
🇮🇹
Acquaviva delle fonti, Italy
Onze-Lieve-Vrouw (OLV) Ziekenhuis
🇧🇪
Aalst, Belgium
Universitair Ziekenhuis (UZ) Brussel
🇧🇪
Brussels, Belgium
University Hospital Center Split
🇭🇷
Split, Croatia