Clinical trial NCT05373862: A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Official title: Clinical Evaluation of Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar-related Atrial Tachycardia
Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Ventricular Tachycardia
Premature Ventricular Complex
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Up to 7 days of index procedure on Day 1
measure: Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter
timeFrame: Up to 7 days of index procedure on Day 1
Secondary outcomes:
measure: Number of Responders for Physician Assessment for Maneuverability and Handling
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Signal Collection and Quality
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Pacing
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Catheter Design
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Workflow
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Catheter Visualization
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Catheters Interactions
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Arrhythmogenicity
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Ability to Characterize the Tissue
timeFrame: Up to 29 weeks
measure: Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
timeFrame: Up to 29 weeks
measure: Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure
timeFrame: Up to 7 days of index procedure on Day 1
measure: Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter
timeFrame: Up to 7 days of index procedure on Day 1
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouw (OLV) Ziekenhuis
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis (UZ) Brussel
city: Split
country: Croatia
facility: University Hospital Center Split
city: Acquaviva delle fonti
country: Italy
facility: Ospedale Generale Regionale Francesco Miulli (F. Miulli)
Study officials:
affiliation: Biosense Webster, Inc.
name: Biosense Webster, Inc. Clinical Trial
role: STUDY_DIRECTOR
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