ECG-Based Ablation Guidance
Novel Catheter Guidance System for RF Ablation of Ventricular Arrhythmias
Heart disease is a significant problem leading to 465,000 deaths each year in the US alone. As many as 65% of these deaths may be caused by ventricular tachycardia (VT), a fast and potentially lethal cardiac arrhythmia. Patients at risk of ventricular tachycardia (VT) or ventricular fibrillation (VF) are generally treated with an Implantable Cardioverter Defibrillator (ICD). ICDs have been proven to be very successful in terminating VT or VF, but do not prevent initiation of the arrhythmia.
Radio Frequency Ablation (RFA) of the arrhythmic focus has the potential of preventing VT or VF from occurring. In RFA, a catheter is guided to with 2-3 mm of the arrhythmic focus and RF energy is deliver to create a small scar that interrupts the errant electric circuit in the heart causing the VT or VF. Current ablation guidance techniques require the patient to be in VT for a sustained period while the ventricle is mapped in order to identify the site of origin of the VT. However, the majority of VT is hemodynamically unstable, ruling out RF Ablation procedures.
Vivonics, Inc., working with researchers at MIT, has implemented and tested a system to guide the RFA catheter to the proper location using data recorded during only a few seconds of the VT. The system uses approximately 60 ECG electrodes on the torso to record body surface potentials and calculates the location of the origin of the VT. The calculation uses a single equivalent moving dipole (SEMD) model of the arrhythmia electrical activity and solves the so-called inverse problem identifying the dipole parameters most likely to generate the pattern of body surface potentials measured. As the RFA catheter is moved within the heart, the SEMD algorithm is repeatedly applied to track the catheter and guide it to the previously mapped location of the VT origin, at which point the curative energy can be delivered.
Initial animal experiments with the prototype system have been completed demonstrating adequacy of the guidance information. We are current seeking a strategic investor or acquirer to fund system refinement IDE submission and clinical trials.
*Product is under development, not yet FDA approved