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| ID | Type | Description | Link |
|---|---|---|---|
| BWI202307 | Other Identifier | Biosense Webster, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping Catheter | Experimental | Participants scheduled to have a clinically indicated catheter mapping and ablation procedure for management of a cardiac arrhythmias will undergo catheter mapping and ablation procedure using paddle-shaped, high-density, multi-electrode mapping catheter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter | Device | High-density, multi-electrode mapping catheter will be used for the procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | 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. | Up to 7 days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Biosense Webster, Inc. Clinical Trial | Biosense Webster, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan | Recruiting | Bruges | 8000 | Belgium | ||
| Jessa Ziekenhuis |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| 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. | 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. | 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. | 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. | Up to 7 days post index procedure |
| Recruiting |
| Hasselt |
| 3500 |
| Belgium |
| Hopital les Franciscaines of Nimes | Withdrawn | Nîmes | 30000 | France |
| CHU de Bordeaux - Hospital Haut-Leveque | Recruiting | Pessac | 33604 | France |
| Chu Rennes Hopital Pontchaillou | Recruiting | Rennes | 35033 | France |
| Vilnius University Hospital Santaros Clinics | Recruiting | Vilnius | 08406 | Lithuania |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D009202 | Cardiomyopathies |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D005117 | Cardiac Complexes, Premature |
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