A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter (OPTIMUM)

Biosense Webster

Status: Completed

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

Treatments: Device: OPTRELL Mapping Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT04983797

BWI_2019_02 (Other Identifier)

CIV-BE-21-04-036524 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.

Enrollment: 31 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, 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, 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 Participant 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 Ventricular Tachycardia (VT) participants
• LVEF <= 40% for participants with atrial arrhythmia
• Documented intracardiac thrombus as detected on imaging
• 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)
• Implanted with a prosthetic valve
• 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)

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31 participants in 1 patient group

OPTRELL Mapping Catheter

Experimental group

Description:

Participants diagnosed with cardiac arrhythmias 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 OPTRELL mapping catheter.

Treatment:

Device: OPTRELL Mapping Catheter