Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Premature Ventricular Complex, Scar-related Atrial Tachycardia, Ventricular Tachycardia
Conditions
Brief summary
The purpose of this study is to assess the performance and safety of using the investigational catheter.
Interventions
DEVICENUVISION NAV Ultrasound Catheter
Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with and candidate for clinically-indicated cardiac ablation procedure for the management of ventricular tachycardia, premature ventricular complex, scar-related atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included) * Signed participants Informed Consent Form (ICF) * Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion criteria
* Structural heart defect which can only be repaired by cardiac surgery * Pericarditis within 6 months * Left ventricular ejection fraction (LVEF) less than or equal to (\<=) 25 percent (%) for ventricular tachycardia (VT) participants * LVEF \<= 40% for participants with atrial arrhythmia * History of chronic gastro-intestinal medical problems involving the esophagus, stomach and/or untreated acid reflux * History of abnormal bleeding and/or clotting disorder * Clinically significant infection or sepsis * History of stroke or transient ischemic attack (TIA) within the past 6 months of enrollment * Uncontrolled heart failure or New York Heart Association (NYHA) function class IV * Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days) * Implanted with a mechanical valve * Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation * Any of the following within 6 months of enrollment: major surgery except for the index procedure, myocardial infarction, unstable angina, percutaneous coronary intervention * Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled bradyarrhythmia's, ventricular arrhythmias, hyperthyroidism, or significant coagulation disorder) * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter | At Day 1 | Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported. |
| Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter | From day of index procedure (Day 1) up to 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures | Day 1 | 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. |
| Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Day 1 | 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. |
| Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter | 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 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. |
| Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure | From day of index procedure (Day 1) up to 7 days | 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. |
| Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Day 1 | 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. |
Countries
Croatia, Israel, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NUVISION NAV Ultrasound Catheter Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC). | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | NUVISION NAV Ultrasound Catheter | — |
|---|---|---|
| Age, Continuous | 64.1 Years STANDARD_DEVIATION 13.41 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 2 / 30 |
| serious Total, serious adverse events | 2 / 30 |
Outcome results
Primary
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
Population: Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NUVISION NAV Ultrasound Catheter | Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter | 0 Participants |
Primary
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
Population: Per Protocol (PP) analysis set included all enrolled participants who met the study eligibility criteria and in whom assessments were performed with the NUVISION NAV ultrasound catheter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUVISION NAV Ultrasound Catheter | Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter | 100.0 Percentage of participants |
Secondary
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
Population: Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 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 | 0 Participants |
Secondary
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
Population: Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUVISION NAV Ultrasound Catheter | Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure | 2 SAEs |
Secondary
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
Population: PP analysis set included all enrolled participants who met study eligibility criteria and in whom assessments were performed with the NUVISION NAV ultrasound catheter. Here, 'n' (number analyzed) refers to number of participants analyzed for specified categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Initial catheter introduction insert catheter into sheath | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Advance catheter into heart | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Visualize catheter on fluoroscopy | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Deflection reach | 6.5 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Deflection degree (bi-directional) | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Torqability | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Ability to maintain torque | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Tip rotation knob functionality | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Catheter tip rotation | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Ability to steer catheter within anatomy Manipulate catheter in right atrium (RA) | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Manipulate catheter in left atrium (LA) | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Ability to cross with catheter to LA | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Manipulate catheter in right ventricle (RV) | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Manipulate catheter in left ventricle (LV) | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Catheter performance assessment deflection control | 7.0 Score on a scale |
Secondary
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
Population: PP analysis set: all enrolled participants who met study eligibility criteria and in whom assessments were performed with NUVISION NAV ultrasound catheter. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure; 'n' (number analyzed) refers to number of participants analyzed for specified categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Contouring, value of drawing CARTOSOUND contours on 2D ultrasound image | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | On dual-plane | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | On multi-plane | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | General did CARTO integration help you to orient in multi-plane? | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Did CARTO integration help you to orient in 4D? | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Did image on CARTO screen change as predicted when deflecting in anterior and posterior directions? | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | How useful was the 'store clip' on CARTO? | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Was troubleshooting information provided by the system helpful? | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Was the green tip overlay on the different planes useful? | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | Was the indication of Live vs. Review Modes clear enough? | 6.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures | How useful was intracardiac echocardiography (ICE) guidance for performing the transseptal puncture? | 7.0 Score on a scale |
Secondary
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
Population: PP analysis set: all enrolled participants who met study eligibility criteria and in whom assessments were performed with NUVISION NAV ultrasound catheter. Here, 'n' (number analyzed) refers to number of participants analyzed for specified categories.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NUVISION NAV Ultrasound Catheter | Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures | Do you think that the NUVISION NAV ultrasound catheter is an acceptable alternative to TEE? | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures | What is your overall satisfaction of the NUVISION NAV ultrasound catheter? | 7.0 Score on a scale |
| NUVISION NAV Ultrasound Catheter | Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures | Would you recommend the NUVISION NAV ultrasound catheter to fellow physicians? | 7.0 Score on a scale |