Atrial Fibrillation, Atrial Flutter
Conditions
Keywords
Arrhythmia, cavo-tricuspid isthmus, atrial fibrillation, atrial fibrillation ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAmigo™ Robotic Catheter Manipulation
Ablation is a standard procedure that patients may undergo for the atrial flutter. In this study, this group will be assigned to robotic catheter manipulation.
DEVICEManual Catheter Manipulation
Ablation is a standard procedure that patients may undergo for the atrial flutter. In this study, this group will be assigned to manual catheter manipulation.
Sponsors
Catheter Robotics, Inc.
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contact Force Through Measurement of Force-time Integral (FTI) | At time of the ablation procedure, which typically lasts 30-60 minutes | Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy Time Measurements | at time of ablation procedure | Determine fluoroscopy time to reach CTI block. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Manual Catheter Manipulation 25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.
Manual Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to manual catheter manipulation. | 25 |
| Amigo™ Robotic Catheter Manipulation 25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.
Amigo™ Robotic Catheter Manipulation: Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to robotic catheter manipulation. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Amigo™ Robotic Catheter Manipulation | Total | Manual Catheter Manipulation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 50 Participants | 25 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 19 Participants | 36 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Contact Force Through Measurement of Force-time Integral (FTI)
Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System
Time frame: At time of the ablation procedure, which typically lasts 30-60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Catheter Manipulation | Contact Force Through Measurement of Force-time Integral (FTI) | 471 gm/s | Standard Deviation 179 |
| Amigo™ Robotic Catheter Manipulation | Contact Force Through Measurement of Force-time Integral (FTI) | 571 gm/s | Standard Deviation 278 |
Secondary
Fluoroscopy Time Measurements
Determine fluoroscopy time to reach CTI block.
Time frame: at time of ablation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Catheter Manipulation | Fluoroscopy Time Measurements | 3.8 minutes | Standard Deviation 2.3 |
| Amigo™ Robotic Catheter Manipulation | Fluoroscopy Time Measurements | 6.8 minutes | Standard Deviation 4.4 |