Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation, Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/17/2018 |
| Start Date: | March 2015 |
| End Date: | March 30, 2018 |
The purpose of this study is to compare standard manual and robotically controlled catheter
ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of
the CTI is standard treatment for patients with a history of atrial flutter, and those
undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation
are used in standard clinical practice at The University of California, San Diego (UCSD) for
ablation.
ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of
the CTI is standard treatment for patients with a history of atrial flutter, and those
undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation
are used in standard clinical practice at The University of California, San Diego (UCSD) for
ablation.
Dr. Gregory Feld, M.D. is conducting a research study to find out more about the effects of
using the Amigo™ Robotic System for ablation of the cavo-tricuspid isthmus (flutter isthmus)
on catheter stability (stabilization of the catheter during the procedure in order to prevent
movement and dislodgement) using a combination of contact force (a measurement of the force
applied by the catheter tip against the tissue during the ablation procedure), location, and
duration measurements during ablation of the atrial flutter circuit. Published studies have
indicated that robotic catheter manipulation is safe, may reduce patient and physician x-ray
exposure, and ablation procedure time. Measuring contact force has also been shown to improve
both short-term and long-term procedure success. However, research on ablation of the CTI
specifically, is limited. This is a randomized study comparing robotic catheter manipulation
using the Amigo Robotic System to manual catheter manipulation for ablation of the CTI on
measures including catheter stability, contact force, procedure time, and fluoroscopy (X-ray)
time.
The ablation procedure is standard of care, however, if patients chose to enroll in the study
they will be randomized to one of two groups: either manual or robotic catheter manipulation.
Throughout the procedure, research personnel will collect information from the procedure
including measurements of contact force, catheter stability, procedure duration, and
fluoroscopy (X-ray) time. If, in addition to ablation of the cavo-tricuspid isthmus for
atrial flutter, a patient is scheduled to undergo ablation of the left atrium for atrial
fibrillation or left atrial flutter, this will be performed subsequently in a standard
manner, and will not be considered part of the research. Ablation of the CTI generally takes
45-60 minutes regardless of the technique used for manipulation of the catheters.
The patient's participation in the study will only last one day, the length of study
procedure. There is no follow up associated with this study. All subjects will received
standard of care treatment following their ablation.
using the Amigo™ Robotic System for ablation of the cavo-tricuspid isthmus (flutter isthmus)
on catheter stability (stabilization of the catheter during the procedure in order to prevent
movement and dislodgement) using a combination of contact force (a measurement of the force
applied by the catheter tip against the tissue during the ablation procedure), location, and
duration measurements during ablation of the atrial flutter circuit. Published studies have
indicated that robotic catheter manipulation is safe, may reduce patient and physician x-ray
exposure, and ablation procedure time. Measuring contact force has also been shown to improve
both short-term and long-term procedure success. However, research on ablation of the CTI
specifically, is limited. This is a randomized study comparing robotic catheter manipulation
using the Amigo Robotic System to manual catheter manipulation for ablation of the CTI on
measures including catheter stability, contact force, procedure time, and fluoroscopy (X-ray)
time.
The ablation procedure is standard of care, however, if patients chose to enroll in the study
they will be randomized to one of two groups: either manual or robotic catheter manipulation.
Throughout the procedure, research personnel will collect information from the procedure
including measurements of contact force, catheter stability, procedure duration, and
fluoroscopy (X-ray) time. If, in addition to ablation of the cavo-tricuspid isthmus for
atrial flutter, a patient is scheduled to undergo ablation of the left atrium for atrial
fibrillation or left atrial flutter, this will be performed subsequently in a standard
manner, and will not be considered part of the research. Ablation of the CTI generally takes
45-60 minutes regardless of the technique used for manipulation of the catheters.
The patient's participation in the study will only last one day, the length of study
procedure. There is no follow up associated with this study. All subjects will received
standard of care treatment following their ablation.
Inclusion Criteria:
- Must be scheduled to undergo radiofrequency catheter ablation of the cavo-tricuspid
isthmus for atrial fibrillation (AF) or atrial flutter (AFL) according to appropriate
clinical indications.
- Must be able and willing to provide written informed consent
- Must be at least 18 years old.
Exclusion Criteria:
- Patient's refusal to participate in the study
- Lack of indication for CTI ablation (eg: prior CTI ablation with persistent
bidirectional isthmus block)
- Pregnancy
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