Ventricular Tachycardia
Conditions
Keywords
arrhythmia, ventricular tachycardia, ablation, mapping, electrophysiology
Brief summary
This is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects will be evaluated acutely and will be followed clinically at 1, 6 and 12 months post-treatment.
Detailed description
Catheter ablation of ventricular tachycardia (VT) is greatly facilitated by using a substrate mapping approach - that is, mapping of the left ventricle during sinus or paced rhythm to identify diseased myocardium. Using three dimensional electroanatomical mapping, it is possible to reconstruct an anatomical rendering of the left ventricle based on voltage. For hemodynamically stable or unstable VTs, various electrophysiologic maneuvers can then be used to identify the critical portions of the VT circuit within the scar (entrainment mapping, identification of diastolic potentials, identification of electrically-unexcitable scar, fractionated potentials and pace mapping). These methods are limited by the resolution of the substrate map, accuracy of catheter manipulation, and operator skill. To this end, a magnetic navigation system has been developed that allows for remote cardiac mapping. When used in concert with a compatible electroanatomical mapping system, it is possible to create a high-density ventricular substrate map of healed myocardial infarction. By removing the necessity for technical skill with catheter manipulation, this system has the potential for both improving the efficacy of VT ablation and expanding the clinical use of this substrate mapping approach. Recently, a higher-powered, irrigated tip catheter has become available in certain markets for use in cardiac arrhythmia ablations. This study will evaluate the outcomes of using this magnetic irrigation ablation catheter during mapping and ablation of VT while also using remote magnetic navigation.
Interventions
DEVICEMagnetic irrigated ablation catheter
Magnetic irrigated catheter to be used with the magnetic navigation system
Sponsors
Stereotaxis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be between the ages of 18 - 80 years * Willing to provide prior written informed consent per local ethics committee guidelines * Subjects must present with ventricular tachycardia, characterized by: history of myocardial scar and spontaneous ventricular tachycardia * Able to be safely exposed to static magnetic fields * No in-situ devices are present or any in-situ devices have been verified to be compatible to magnetic fields
Exclusion criteria
* Presence of a mobile ventricular thrombus * Inability to access the left ventricle * Subjects must not have any contraindications to short-term anticoagulation * Subjects must not have a life expectancy of \<1 year due to a medical illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Free From VT at 1 Year Post-Treatment | 1 Year follow-up | In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy. |
Countries
Czechia, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Magnetic Irrigated Ablation Catheter Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA). | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | Magnetic Irrigated Ablation Catheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 33 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 7 |
| History of cerebro-vascular accident (CVA) | 9 participants |
| History of diabetes | 16 participants |
| History of transient ischemic attack (TIA) | 3 participants |
| ICD implanted prior to the ablation procedure | 38 participants |
| Left Ventricular Ejection Fraction | 31.5 percent |
| Pre-procedural arrhythmia treatment with amiodarone | 34 participants |
| Pre-procedural arrhythmia treatment with beta-blockers | 47 participants |
| Region of Enrollment Czech Republic | 32 participants |
| Region of Enrollment Germany | 9 participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Percentage of Participants Free From VT at 1 Year Post-Treatment
In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.
Time frame: 1 Year follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magnetic Irrigated Ablation Catheter | Percentage of Participants Free From VT at 1 Year Post-Treatment | 62 percentage of participants free from VT |