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

Biosense Webster

Status: Completed

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05373862

CIV-22-03-039047 (Other Identifier)

BWI_2021_01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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