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This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures.
Key to the success of an electrophysiology procedure is the ability to accurately map, sense and pace the heart. Electrophysiology mapping catheters are available in a variety of shapes and electrode configurations. The majority of these catheters are manipulated manually by the physician. The Vdrive simplifies these manipulations by allowing an operator to mechanically advance, retract, rotate, deflect and maneuver a circular mapping catheter. The circular mapping catheter is not altered in structure, function or indication in the same manner as the predicate device (Cardiodrive Catheter Advancement System).
This is a prospective, randomized, non-blinded, controlled study comparing manual navigation of a circular mapping catheter with mechanical navigation by the Vdrive. A total of 120 patients are expected to complete the study: 80 patients in the Vdrive navigation arm and 40 patients in the manual navigation arm. Patients will be enrolled at a minimum of one site in the European Union where the product is currently marketed and the United States, where the Vdrive is considered to be investigational.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Lasso navigation | Active Comparator | Use of conventional manual navigation techniques with the Lasso catheter |
|
| Vdrive Lasso navigation | Experimental | Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vdrive Lasso navigation | Device | Remote robotic Lasso navigation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups. | Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05. | Peri-procedural |
| Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups. | The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05. | 7 days Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qun Sha, MD | Stereotaxis Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States | ||
| Texas Cardiac Arrhythmia Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Lasso Navigation | Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter |
| FG001 | Vdrive Lasso Navigation | Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Vdrive Lasso navigation: Remote robotic Lasso navigation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Lasso Navigation | Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter |
| BG001 | Vdrive Lasso Navigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups. | Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05. | All adverse events reported by the sites were independently adjudicated by the data safety monitory, DSM. | Posted | Number | Pulmonary Veins | Peri-procedural | Pulmonary Veins | Participants |
|
If an event was reported by a site as a serious adverse event, SAE, and possibly, probably, or definitely related to the device or the procedure, it is included in the tabulation and the analysis of major adverse events through seven (7) day follow-up.
All adverse events reported by the sites were independently adjudicated by a Data Safety Monitor, DSM.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Lasso Navigation | Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pseudoaneurysm | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Qun Sha M.D. (Study Director) | Stereotaxis, Inc. | 314-678-6143 | qun.sha@stereotaxis.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Manual Lasso navigation |
| Procedure |
Manually maneuver a Lasso catheter |
|
| Austin |
| Texas |
| 78705 |
| United States |
| Baylor Research Institute | Dallas | Texas | 75204 | United States |
| ZNA Campus Middelheim Lindendreef 1 | Antwerp | Antwerpen | 2020 | Belgium |
| IKFE HDZ GbmH | Bad Oeynhausen | Bad Oeynhausen | 32545 | Germany |
Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Vdrive Lasso navigation: Remote robotic Lasso navigation
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Use of conventional manual navigation techniques with the Lasso catheter
Manual Lasso navigation: Manually maneuver a Lasso catheter
| OG001 | Vdrive Lasso Navigation | Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Vdrive Lasso navigation: Remote robotic Lasso navigation |
|
|
|
| Primary | Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups. | The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05. | Posted | Number | participants | 7 days Follow-up |
|
|
|
|
| 1 |
| 43 |
| 2 |
| 43 |
| EG001 | Vdrive Lasso Navigation | Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Vdrive Lasso navigation: Remote robotic Lasso navigation | 3 | 77 | 6 | 77 |
| Cardiac Tamponade | Surgical and medical procedures | Systematic Assessment |
|
| Bleeding | Surgical and medical procedures | Systematic Assessment |
|
| Dementia | Surgical and medical procedures | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |