Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Completed · Phase 3
Conditions studied: Atrial Fibrillation
In brief
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 facts
- Study ID
- NCT01656772
- Run by
- Stereotaxis
- People needed
- 120
- Starts
- 2012-08-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2015-07-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Central Baptist Hospital — Lexington, Kentucky, United States
- Texas Cardiac Arrhythmia Institute — Austin, Texas, United States
- Baylor Research Institute — Dallas, Texas, United States
- ZNA Campus Middelheim Lindendreef 1 — Antwerp, Antwerpen, Belgium
- IKFE HDZ GbmH — Bad Oeynhausen, Bad Oeynhausen, Germany
Full record on ClinicalTrials.gov
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