Trial Outcomes & Findings for Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study (NCT NCT01656772)

NCT ID: NCT01656772

Last Updated: 2015-07-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: Peri-procedural
• Results posted on: 2015-07-01

Participant Flow

Participant milestones

Measure	Manual Lasso Navigation Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter	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
Overall Study STARTED	43	77
Overall Study COMPLETED	43	77
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study

Baseline characteristics by cohort

Measure	Manual Lasso Navigation n=43 Participants Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter	Vdrive Lasso Navigation n=77 Participants Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Vdrive Lasso navigation: Remote robotic Lasso navigation	Total n=120 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 9.2 • n=93 Participants	62.4 years STANDARD_DEVIATION 9.8 • n=4 Participants	62.6 years STANDARD_DEVIATION 9.5 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	14 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Male	34 Participants n=93 Participants	63 Participants n=4 Participants	97 Participants n=27 Participants
Region of Enrollment Belgium	11 participants n=93 Participants	23 participants n=4 Participants	34 participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	33 participants n=4 Participants	53 participants n=27 Participants
Region of Enrollment Germany	12 participants n=93 Participants	21 participants n=4 Participants	33 participants n=27 Participants

PRIMARY outcome

Timeframe: Peri-procedural

Population: All adverse events reported by the sites were independently adjudicated by the data safety monitory, DSM.

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.

Outcome measures

Measure	Manual Lasso Navigation n=167 Pulmonary Veins Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter	Vdrive Lasso Navigation n=301 Pulmonary Veins Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Vdrive Lasso navigation: Remote robotic 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 Pulmonary Veins	295 Pulmonary Veins

PRIMARY outcome

Timeframe: 7 days Follow-up

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.

Outcome measures

Measure	Manual Lasso Navigation n=43 Participants Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter	Vdrive Lasso Navigation n=77 Participants Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Vdrive Lasso navigation: Remote robotic 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 participants	3 participants

Adverse Events

Manual Lasso Navigation

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Vdrive Lasso Navigation

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Manual Lasso Navigation n=43 participants at risk Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter	Vdrive Lasso Navigation n=77 participants at risk Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Vdrive Lasso navigation: Remote robotic Lasso navigation
Surgical and medical procedures Pseudoaneurysm	0.00% 0/43 • 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.	1.3% 1/77 • 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.
Surgical and medical procedures Cardiac Tamponade	0.00% 0/43 • 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.	1.3% 1/77 • 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.
Surgical and medical procedures Bleeding	0.00% 0/43 • 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.	1.3% 1/77 • 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.
Surgical and medical procedures Dementia	2.3% 1/43 • 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.	0.00% 0/77 • 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.

Other adverse events

Measure	Manual Lasso Navigation n=43 participants at risk Use of conventional manual navigation techniques with the Lasso catheter Manual Lasso navigation: Manually maneuver a Lasso catheter	Vdrive Lasso Navigation n=77 participants at risk Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter Vdrive Lasso navigation: Remote robotic Lasso navigation
Cardiac disorders Atrial Flutter	4.7% 2/43 • 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.	0.00% 0/77 • 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.
Cardiac disorders Atrial Fibrillation	0.00% 0/43 • 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.	5.2% 4/77 • 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.
Vascular disorders Hematoma	0.00% 0/43 • 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.	2.6% 2/77 • 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.

Additional Information

Qun Sha M.D. (Study Director)

Stereotaxis, Inc.

Phone: 314-678-6143

Email: qun.sha@stereotaxis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60