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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
60
High-density, multi-electrode mapping catheter will be used for the procedure.
AZ Sint-Jan
Bruges, Belgium
RECRUITINGJessa Ziekenhuis
Hasselt, Belgium
RECRUITINGHopital les Franciscaines of Nimes
Nîmes, France
WITHDRAWNCHU de Bordeaux - Hospital Haut-Leveque
Pessac, France
RECRUITINGChu Rennes Hopital Pontchaillou
Rennes, France
RECRUITINGVilnius University Hospital Santaros Clinics
Vilnius, Lithuania
RECRUITINGIncidence 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.
Time frame: 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.
Time frame: Up to 7 days post index procedure
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.
Time frame: 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
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.
Time frame: Up to 7 days post index procedure
Incidence of all Other SAEs Not Related to the Investigational Catheter
Incidence with all other SAEs not related to the investigational catheter will be reported.
Time frame: Up to 7 days post index procedure
Incidence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter
Incidence with non-serious AEs related to the investigational catheter will be reported.
Time frame: 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
Incidence of completion with all pre-ablation epicardial mapping requirements and any clinically indicated epicardial mapping with the investigational catheter as per physician's discretion, 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.
Time frame: Up to 7 days post index procedure
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