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

Korábbi kezelés

• Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
• Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior
• 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

Más betegség

• Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause
• History of blood clotting or bleeding abnormalities (example hypercoagulable state)
• Myocardial infarction within the past 2 months (60 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
• 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])
• Presence of a condition that precludes vascular access

Laborértékek

• Left ventricular ejection fraction(LVEF) less than or equal to (<=) 25 percentage (%) for participants with ventricular arrhythmia
• LVEF <= 40% for participants with atrial arrhythmia

Életkor

• 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

Egyéb

• Patients requiring left atrial procedures: left atrial size greater than (>) 55 millimeter (mm)
• Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)
• Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months (365 days)
• 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
• Atrial septal closure within the past 6 weeks (42 days)

• 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