A Phase 3 interventional study of Vdrive Lasso navigation and Manual Lasso navigation in Atrial Fibrillation, sponsored by Stereotaxis. Completed at 5 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-01.
Sponsored by Stereotaxis · Phase 3, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 120 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Stereotaxis is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Use of conventional manual navigation techniques with the Lasso catheter
Procedure: Manual Lasso navigation
Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Device: Vdrive Lasso navigation
Remote robotic Lasso navigation
Manually maneuver a Lasso catheter
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.
Time frame: 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.
Time frame: 7 days Follow-up
| Milestone | Manual Lasso Navigation | Vdrive Lasso Navigation |
|---|---|---|
| Started | 43 | 77 |
| Completed | 43 | 77 |
| Not completed | 0 | 0 |
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.
| Pulmonary Veins | Manual Lasso Navigation | Vdrive Lasso Navigation |
|---|---|---|
| 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. | 167 | 295 |
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.
| participants | Manual Lasso Navigation | Vdrive Lasso Navigation |
|---|---|---|
| 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. | 1 | 3 |
Collected over 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.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Manual Lasso Navigation | — | 1/43 (2.3%) | 2/43 (4.7%) |
| Vdrive Lasso Navigation | — | 3/77 (3.9%) | 6/77 (7.8%) |
| Event | Manual Lasso Navigation | Vdrive Lasso Navigation |
|---|---|---|
| DementiaSurgical and medical procedures | 1/43 | 0/77 |
| PseudoaneurysmSurgical and medical procedures | 0/43 | 1/77 |
| Cardiac TamponadeSurgical and medical procedures | 0/43 | 1/77 |
| BleedingSurgical and medical procedures | 0/43 | 1/77 |
| Event | Manual Lasso Navigation | Vdrive Lasso Navigation |
|---|---|---|
| Atrial FibrillationCardiac disorders | 0/43 | 4/77 |
| Atrial FlutterCardiac disorders | 2/43 | 0/77 |
| HematomaVascular disorders | 0/43 | 2/77 |
| Age, Continuous(years) | Manual Lasso Navigation | Vdrive Lasso Navigation | Total |
|---|---|---|---|
| Mean | 62.8 ± 9.2 | 62.4 ± 9.8 | 62.6 ± 9.5 |
| Sex: Female, Male(Participants) | Manual Lasso Navigation | Vdrive Lasso Navigation | Total |
|---|---|---|---|
| Female | 9 | 14 | 23 |
| Male | 34 | 63 | 97 |
| Region of Enrollment(participants) | Manual Lasso Navigation | Vdrive Lasso Navigation | Total |
|---|---|---|---|
| Belgium | 11 | 23 | 34 |
| United States | 20 | 33 | 53 |
| Germany | 12 | 21 | 33 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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