The purpose of this study is to assess the performance and safety of using the investigational catheter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.
KBC Split
Split, Croatia
Yitzhak Shamir Medical Center
Ẕerifin, Israel
Centro Cardiologico Monzino
Milan, Italy
Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter
Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported.
Time frame: At Day 1
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
Number of participants with SAEs within 7 days of index procedure related to the NUVISION NAV ultrasound catheter were reported. An AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: From day of index procedure (Day 1) up to 7 days
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures
Physician assessment of deployment, maneuverability and navigational features with the NUVISION NAV ultrasound catheter during the study procedures were reported. The physician's feedback was collected after each study procedure for each investigational catheter through a questionnaire-based survey consisting of 15 question/sub-question. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of greater than or equal to (\>=) 4 were considered satisfaction.
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures
Physician assessment of imaging quality acquired with the NUVISION NAV ultrasound catheter during the study procedures was reported. The quality of image acquired with NUVISION NAV ultrasound catheter and displayed by CARTO software was assessed through physician's feedback on 11 question/sub-questions. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of \>=4 were considered satisfaction.
Time frame: Day 1
Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures
Physicians overall feedback on the NUVISION NAV ultrasound catheter during the study procedure was reported. The overall feedback on the NUVISION NAV ultrasound catheter was assessed through physician's feedback on 3 question/sub-questions. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of \>=4 were considered satisfaction. TEE is transesophageal echocardiography.
Time frame: Day 1
Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure
Number of SAEs excluding NUVISION NAV ultrasound catheter related SAE within 7 days of index procedure was reported. AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: From day of index procedure (Day 1) up to 7 days
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
Number of participants with non-serious adverse events within 7 days of index procedure related to the NUVISION NAV ultrasound catheter were reported. AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device.
Time frame: From day of index procedure (Day 1) up to 7 days