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.
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)
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
Single group
Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
DeviceHigh-density, multi-electrode mapping catheter will be used for the procedure.
Occurrence 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.
Occurrence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping
Occurrence 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.
Investigator Assessment of Deployment; Visualization; Maneuverability and Signal Quality
Physician feedback on the catheter deployment, visualization, maneuverability, and signal quality acquired with the investigational catheter for mapping of the atria and ventricles, inclusive of endocardial and epicardial spaces, using a physician-completed survey, using a Likert scale of 1 to 7 (1=poor and 7=excellent) will be summarized.
Occurrence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion
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.
Occurrence of all Other SAEs Not Related to the Investigational Catheter
Occurrence of all other SAEs not related to the investigational catheter will be reported.
Occurrence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter
Occurrence of non-serious AEs related to the investigational catheter will be reported.
Click on the lead sponsor to view all of their trials.