A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter

NCT07116525 | Recruiting FDA Device

• 1 other identifier: BWI202307
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 6

Brief Summary

The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.

Conditions

Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Ventricular Procedures; Ventricular Tachycardia; Ischemic Ventricular Tachycardia; Non-ischemic Ventricular Tachycardia; Cardiomyopathy; Idiopathic Ventricular Tachycardia; Premature Ventricular Contraction; Scar-related Atrial Tachycardia

Outcome Measures

Primary Outcomes (2)

• Incidence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping

  A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

  Up to 7 days post index procedure

• Incidence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping

  Incidences of all pre-ablation endocardial mapping requirements and any clinically indicated endocardial mapping with the investigational catheter, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.

  Up to 7 days post index procedure

Secondary Outcomes (5)

• Investigator Assessment of Deployment; Visualization; Maneuverability and Signal Quality

  Up to 7 days post index procedure

• Incidence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion

  Up to 7 days post index procedure

• Incidence of all Other SAEs Not Related to the Investigational Catheter

  Up to 7 days post index procedure

• Incidence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter

  Up to 7 days post index procedure

• Incidence of Completion of all Pre-ablation Epicardial Mapping Requirements and Any Clinically Indicated Epicardial Mapping With the Investigational Catheter as Per Physician's Discretion

  Up to 7 days post index procedure

Study Arms (1)

Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping Catheter

EXPERIMENTAL

Participants scheduled to have a clinically indicated catheter mapping and ablation procedure for management of a cardiac arrhythmias will undergo catheter mapping and ablation procedure using paddle-shaped, high-density, multi-electrode mapping catheter.

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

Interventions

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

High-density, multi-electrode mapping catheter will be used for the procedure.

Arrhythmia Mapping by a Paddle-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 (participant 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 prior to enrollment
• Age 18 years or older
• Signed Patient Informed Consent Form (ICF)
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

You may not qualify if:

• Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause
• Patients requiring left atrial procedures: left atrial size greater than (\>) 55 millimeter (mm)
• Left ventricular ejection fraction(LVEF) less than or equal to (\<=) 25 percentage (%) 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 or appendage closure device within the past 6 weeks (42 days)
• Patients 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (6)

AZ Sint-Jan

Bruges, 8000, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

Hopital les Franciscaines of Nimes

Nîmes, 30000, France

WITHDRAWN

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, 33600, France

RECRUITING

Chu Rennes Hopital Pontchaillou

Rennes, 35033, France

RECRUITING

Vilnius University Hospital Santaros Clinics

Vilnius, 08406, Lithuania

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular; Cardiomyopathies; 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

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

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

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 11, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (3); LI (1); BE (2)