Phase 3
N=120
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01656772 ↗Enrolled (actual)
120
Serious AEs
3.3%
Results posted
Jun 2015
Primary outcome: 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. — 167; 295 Pulmonary Veins — p=0.0405
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vdrive Lasso navigation (Device); Manual Lasso navigation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stereotaxis
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
167; 295 | 0.0405 sig |
| 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. |
1; 3 | .0441 sig |
Summary
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.
Eligibility Criteria
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
- Unable to safely expose subject to a magnetic field
- Prior AF ablation procedure
- Patients with fewer than 4 PVs are excluded
- Patients with persistent AF in whom early recurrence of AF following cardioversion would preclude completion of the pacing maneuvers described in the protocol or patients with other conditions that would similarly preclude completion of the pacing maneuvers
- Contraindication to procedure or unable to return for follow-up
- History of clotting disorder, bleeding abnormalities or contraindication to anticoagulation
- Actively participating in other cardiac device trial(s)
- Currently pregnant
- Under 18 years of age
- Prosthetic valves
- Atrial abnormalities (thrombus, myxoma or baffle)
- Other exclusions per the investigator
Data sourced from ClinicalTrials.gov (NCT01656772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.