Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01656772 | Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study | PHASE3 | COMPLETED | 120 | — | — | Aug 1, 2012 | Dec 1, 2013 | Jul 1, 2015 | 5 | United States, Belgium +1 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Vdrive Lasso navigation | DEVICE | Remote robotic Lasso navigation |
| Manual Lasso navigation | PROCEDURE | Manually maneuver a Lasso catheter |
Inclusion Criteria: * Left atrial AF ablation procedure requiring the use of a Lasso mapping catheter * Subject must be at least 18 years of age * Subject must be male, female of no childbearing potential, or a female that has a negative pregnancy test prior to randomization Exclusion Criteria: *...