Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
DeviceHigh-density, multi-electrode mapping catheter will be used for the procedure.
NCT Number: NCT07116525
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
AZ Sint-Jan, Bruges, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-density, multi-electrode mapping catheter will be used for the procedure.
Time frame: Up to 7 days post index procedure
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
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
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
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 with all other SAEs not related to the investigational catheter will be reported.
Time frame: Up to 7 days post index procedure
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 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.
Contact information is provided by the study sponsor or research team.
Biosense Webster, Inc.
Industry
Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter
Acronym: FEATHER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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