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

NCT05373862 | Completed Results FDA Device

• 2 other identifiers: BWI_2021_01CIV-22-03-039047
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 4

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.

Conditions

Scar-related Atrial Tachycardia; Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Ventricular Tachycardia; Premature Ventricular Complex

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Up to 7 days of index procedure on Day 1

• Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter

  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.

  Up to 7 days of index procedure on Day 1

Secondary Outcomes (13)

• Number of Responders for Physician Assessment for Maneuverability and Handling

  Up to 29 weeks

• Number of Responders for Physician Assessment for Signal Collection and Quality

  Up to 29 weeks

• Number of Responders for Physician Assessment for Pacing

  Up to 29 weeks

• Number of Responders for Physician Assessment for Catheter Design

  Up to 29 weeks

• Number of Responders for Physician Assessment for Workflow

  Up to 29 weeks

Study Arms (1)

Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

EXPERIMENTAL

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.

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

Interventions

Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter DEVICE

Participants scheduled to have a clinically-indicated catheter mapping and ablation procedure using globe-shaped, high-density, multi-electrode mapping catheter for management of atrial procedure (scar-related atrial tachycardia, persistent atrial fibrillation, paroxysmal atrial fibrillation) and Ventricular procedures (ventricular tachycardia, premature ventricular complex).

Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (4)

Onze-Lieve-Vrouw (OLV) Ziekenhuis

Aalst, 9300, Belgium

Location

Universitair Ziekenhuis (UZ) Brussel

Brussels, 1090, Belgium

Location

University Hospital Center Split

Split, 21000, Croatia

Location

Ospedale Generale Regionale Francesco Miulli (F. Miulli)

Acquaviva delle Fonti, 70021, Italy

Location

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MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Cardiac Complexes, Premature

Limitations and Caveats

Study results/conclusions were based on descriptive analysis due to small sample size. Identification of arrhythmia's mechanism was based on common types of arrhythmias, not for all arrhythmias. Comparisons of globe-shaped design with other multi-electrode catheters could only be performed based on physician feedback in the post-procedure survey. Although CARTO system being the latest version, no specific features were developed to maximize the use of catheter's globe-shape design.

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 13, 2022
• Study Start: July 29, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: March 3, 2025
• Results First Posted: March 13, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CR (1); IT (1); BE (2)