Atrial Fibrillation
Conditions
Keywords
magnetic navigation, robotic control, RMT ThermoCool catheter
Brief 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.
Detailed description
Key to the success of an electrophysiology procedure is the ability to accurately map, sense and pace the heart. Electrophysiology mapping catheters are available in a variety of shapes and electrode configurations. The majority of these catheters are manipulated manually by the physician. The Vdrive simplifies these manipulations by allowing an operator to mechanically advance, retract, rotate, deflect and maneuver a circular mapping catheter. The circular mapping catheter is not altered in structure, function or indication in the same manner as the predicate device (Cardiodrive Catheter Advancement System). This is a prospective, randomized, non-blinded, controlled study comparing manual navigation of a circular mapping catheter with mechanical navigation by the Vdrive. A total of 120 patients are expected to complete the study: 80 patients in the Vdrive navigation arm and 40 patients in the manual navigation arm. Patients will be enrolled at a minimum of one site in the European Union where the product is currently marketed and the United States, where the Vdrive is considered to be investigational.
Interventions
DEVICEVdrive Lasso navigation
Remote robotic Lasso navigation
PROCEDUREManual Lasso navigation
Manually maneuver a Lasso catheter
Sponsors
Stereotaxis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Peri-procedural | 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. |
| 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. | 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. |
Countries
Belgium, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Manual Lasso Navigation Use of conventional manual navigation techniques with the Lasso catheter
Manual Lasso navigation: Manually maneuver a Lasso catheter | 43 |
| 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 | 77 |
| Total | 120 |
Baseline characteristics
| Characteristic | Manual Lasso Navigation | Vdrive Lasso Navigation | Total |
|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 9.2 | 62.4 years STANDARD_DEVIATION 9.8 | 62.6 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment Belgium | 11 participants | 23 participants | 34 participants |
| Region of Enrollment Germany | 12 participants | 21 participants | 33 participants |
| Region of Enrollment United States | 20 participants | 33 participants | 53 participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 34 Participants | 63 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 43 | 6 / 77 |
| serious Total, serious adverse events | 1 / 43 | 3 / 77 |
Outcome results
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.
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.
Time frame: 7 days Follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual 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 |
| Vdrive 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. | 3 participants |
p-value: 0.0441Z-statistic
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.
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.
Time frame: Peri-procedural
Population: All adverse events reported by the sites were independently adjudicated by the data safety monitory, DSM.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual 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 |
| Vdrive 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. | 295 Pulmonary Veins |
Comparison: The primary effectiveness endpoint is the successful navigation and EGM recording of each pre-specified pulmonary vein (PV). The RF ablation treatment was not part of the investigational procedure. 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.p-value: 0.0405Farrington and Manning